Systems and methods for collecting and transmitting assay results

ABSTRACT

Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.

CROSS-REFERENCE

This application is a continuation-in-part application of PCTApplication No. PCT/US11/53189, filed Sep. 25, 2011 which isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Existing systems and methods for clinical testing suffer many drawbacksfrom the perspectives of patients, health care professionals, andtaxpayers or insurance companies. Today, consumers can purchase certainspecialized tests from various locations for consumer use. For example,a consumer can purchase a pregnancy test at a pharmacy and review theresults. However, such results are to be viewed by the consumer, and arenot to be relied on by the consumer's physician in forming a diagnosisor treatment plan.

Additionally, if a test result is to be conducted and to be relied on bya doctor, physical samples are transported to a laboratory where thetests on the samples are performed. For example, blood from afingerstick or venous draw is typically collected from a subject at ahospital or physician's office. The blood sample is shipped to aClinical Laboratory Improvement Amendments (CLIA) certified laboratorywhich performs the tests and analysis that is provided to the patient'sdoctor. Such techniques are cumbersome and cause significant delay inproviding the result of a test ordered by a physician, especiallybecause the physical specimens must be transported to a different sitefor analysis. Moreover, the sample collection sites often have limitedhours which further causes inconvenience to patients.

Conventional techniques are also problematic for certain diagnoses. Sometests are time sensitive, and the results of which may take days orweeks to complete. In such a time, a disease can progress past the pointof treatment. This impairs a medical professional's ability to providequality care.

Traditional systems and methods also affect the integrity and quality ofa clinical test due to degradation of a sample that often occurs whiletransporting such sample from the site of collection to the place whereactual analysis of the sample is performed. For examples, analytes decayat a certain rate, and the time delay for analysis can result in loss ofthe sample integrity. Different laboratories also work with differentqualities which can result in varying degrees of error. Each laboratorycan have its own set of references that further introduce a wide rangeof variability in coefficients of variation. Additionally, preparationof samples by hand permit upfront human error to occur from varioussample collection sites. These and other drawbacks inherent in theconventional setup make it difficult to perform longitudinal analysiswith high quality.

Furthermore, the conventional techniques are typically not very costeffective. For example, delays in test results lead to delays indiagnoses and treatments that can have a deleterious effect on apatient's health. For example, a disease may progress further, resultingin the patient needing additional treatment. Payers, such as healthinsurance companies and taxpayers contributing to governmental healthprograms, end up paying more to treat problems that could have beenaverted with more accessible and faster clinical test results.

SUMMARY OF THE INVENTION

A need exists for improved systems and methods that allow higher qualityof care, more rapid and accurate diagnosis and/or treatment.Specifically, there is a considerable need for sample collection,preparation and analysis. A further need exists for easily accessiblesample collection sites, while permitting the analysis of data that canbe relied on by a health care professional.

Systems and methods are further needed for earlier intervention andproviding high quality of care with little variability and reduced humanerror to enable the performance of longitudinal analysis of data.Systems and methods disclosed herein meet this need and provide relatedadvantages as well.

An aspect of the invention is directed a method of evaluating abiological sample collected from a subject, said method comprising: (a)receiving data transmitted from a device placed in or on the subject orat a retailer site, wherein the device is configured to process thebiological sample by: (i) receiving the biological sample; (ii)preparing the biological sample for a subsequent qualitative and/orquantitative evaluation, to yield data necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample;and (iii) transmitting electronically the data to an authorizedanalytical facility and/or an affiliate thereof for performance of saidsubsequent qualitative and/or quantitative evaluation; and (b) analyzingthe data transmitted from the device, at the authorized analyticalfacility and/or the affiliate thereof, to provide said qualitativeand/or quantitative evaluation of said biological sample.

In accordance with another aspect of the invention, a method ofevaluating a biological sample collected from a subject may comprise:(a) receiving electronic data representative of an image of saidbiological sample and/or an image of a physical process or chemicalreaction performed with said biological sample or a portion thereof,said data being transmitted from a device placed in or on the subject orat a designated sample collection site, wherein the device is configuredto process the biological sample by: (i) receiving the biologicalsample; (ii) preparing the biological sample for a subsequentqualitative and/or quantitative evaluation, wherein said preparationyields the electronic data representative of the image of saidbiological sample and/or the image of the physical process or thechemical reaction; and (iii) transmitting the electronic datarepresentative of the image to an authorized analytical facility and/oran affiliate thereof for performance of said subsequent qualitativeand/or quantitative evaluation; wherein the processing generates theelectronic data representative of the image necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample,and (b) analyzing the electronic data representative of the imagetransmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said qualitative and/orquantitative evaluation of said biological sample.

A method of evaluating a plurality of types of biological samplescollected from a subject may be provided in accordance with anotheraspect of the invention. The method may comprise: (a) receiving datatransmitted from a device placed in or on the subject or at a designatedsample collection site, wherein the device is configured to process theplurality of types of biological samples by: (i) receiving the pluralityof types of biological samples; (ii) preparing the biological samplesfor a subsequent qualitative and/or quantitative evaluation, to yielddata necessary for the subsequent qualitative and/or quantitativeevaluation of said plurality of types of biological samples; and (iii)transmitting electronically the data to an authorized analyticalfacility and/or an affiliate thereof for performance of said subsequentqualitative and/or quantitative evaluation; and (b) analyzing the datatransmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said qualitative and/orquantitative evaluation of said plurality of types of biologicalsamples.

An additional aspect of the invention may be directed to a method ofevaluating a biological sample collected from a subject at a designatedsite, said method comprising: (a) collecting and processing thebiological sample at said designated site wherein the sample iscollected by a device that is configured to (i) receive the biologicalsample; (ii) prepare the biological sample for a subsequent qualitativeand/or quantitative evaluation, to yield data necessary for thesubsequent qualitative and/or quantitative evaluation of said biologicalsample; and (iii) transmit the data to a health care provider of anauthorized analytical facility and/or an affiliate thereof forperformance of said subsequent qualitative and/or quantitativeevaluation; and (b) transmitting the data to the authorized analyticalfacility and/or an affiliate thereof; and (c) analyzing the datatransmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said qualitative and/orquantitative evaluation of said biological sample.

Also, aspects of the invention may be directed to a method of evaluatinga biological sample collected from a subject, said method comprising:(a) receiving data transmitted from a device placed in or on the subjector at a designated sample collection site, wherein the device isconfigured to process the biological sample by (i) receiving thebiological sample; (ii) preparing the biological sample for a subsequentqualitative and/or quantitative evaluation, to yield data necessary forthe subsequent qualitative and/or quantitative evaluation of saidbiological sample; and (iii) transmitting the data to a health careprovider of an authorized analytical facility and/or an affiliatethereof for performance of said subsequent qualitative and/orquantitative; and (b) analyzing the data transmitted from the device, atthe authorized analytical facility and/or the affiliate thereof, toprovide said qualitative and/or quantitative evaluation of saidbiological sample; and (c) verifying (x) whether the subject received anorder from a health care professional to undertake said subsequentqualitative and/or quantitative evaluation of said biological sample, or(y) whether the order for the subsequent qualitative and/or quantitativeevaluation of said biological sample is within the policy restrictionsof a payer or a prescribing physician for said subsequent qualitativeand/or quantitative evaluation, and/or (z) whether the subject iscovered by health insurance for said qualitative and/or quantitativeevaluation of the biological sample; wherein said verifying step isperformed prior to, concurrently with, or after steps (a) and/or (b).

A method of performing a pathological study of a biological samplecollected from a subject may be provided in accordance with anotheraspect of the invention. The method may comprise: (a) receivingelectronic data representative of an image of said biological sample, aphysical process and/or chemical reaction performed with said biologicalsample or a portion thereof, wherein the data is received from a deviceplaced in or on the subject or at a designated sample collection site,wherein the device is configured to: (i) receive said biological sample;(ii) prepare the collected biological sample for a subsequentqualitative and/or quantitative evaluation, wherein said preparationyields the electronic data representative of the image of saidbiological sample and/or the chemical reaction; and (iii) transmit theelectronic data representative of the image to a pathologist of anauthorized analytical facility and/or its affiliate thereof; (b)analyzing the electronic data by the pathologist of the authorizedanalytical facility and/or the affiliate thereof, to provide saidqualitative and/or quantitative evaluation.

Additional aspects of the invention may be directed to a method ofperforming a pathological study of a biological sample collected from asubject, said method comprising: (a) receiving electronic datarepresentative of an image of said biological sample and/or a chemicalreaction performed with at least one component from said biologicalsample from a device placed in or on the subject or at a designatedsample collection site, wherein the device is configured to: (i) receivesaid biological sample; (ii) prepare the collected biological sample fora subsequent qualitative and/or quantitative evaluation, wherein saidpreparation yields the electronic data representative of the image ofsaid biological sample and/or the chemical reaction; and (iii) transmitthe electronic data representative of the image to a pathologist of anauthorized analytical facility; (b) analyzing the electronic data by thepathologist of the authorized analytical facility to provide saidsubsequent qualitative and/or quantitative evaluation.

Furthermore, aspects of the invention may be directed to a method ofevaluating a biological sample collected from a subject, said methodcomprising: (a) receiving data transmitted from a device placed in or onthe subject or at a designated sample collection site, wherein thedevice is configured to process the biological sample by: (i) receivingthe biological sample; (ii) preparing the biological sample for asubsequent qualitative and/or quantitative evaluation, to yield datanecessary for the subsequent qualitative and/or quantitative evaluationof said biological sample; and (iii) transmitting electronically thedata to an authorized analytical facility and/or an affiliate thereof;(b) analyzing the data transmitted from the device, at the authorizedanalytical facility and/or the affiliate thereof, to provide saidsubsequent qualitative and/or quantitative evaluation of said biologicalsample.

Additional aspects of the invention may be directed to a method ofevaluating a biological sample collected from a subject, said methodcomprising: (a) receiving data transmitted from a device placed in or onthe subject or at a retailer site, wherein the device is configured toprocess the biological sample by: (i) receiving the biological sample;(ii) preparing the biological sample for a subsequent qualitative and/orquantitative evaluation, to yield data necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample;and (iii) transmitting electronically the data to an authorizedanalytical facility and/or an affiliate thereof; and (b) analyzing thedata transmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said biological sample.

In accordance with additional aspects of the invention, a method ofevaluating a biological sample may comprise: (a) processing, with theaid of a device, a biological sample collected from a subject, whereinthe device is placed in or on the subject or at a designated samplecollection site, wherein the processing generates data necessary for asubsequent qualitative and/or quantitative evaluation of said biologicalsample, and wherein the device is configured to (i) receive thebiological sample; (ii) prepare the biological sample for the subsequentqualitative and/or quantitative evaluation; and (iii) transmit the datato an authorized analytical facility and/or an affiliate thereof; (b)transmitting the data from the device, at the authorized analyticalfacility and/or the affiliate thereof, to provide said subsequentqualitative and/or quantitative evaluation of said biological sample;and (c) verifying whether the subject has healthcare coverage, whereinsaid verifying step is performed prior to, concurrently with, or aftersteps (a) and/or (b).

A method of evaluating a biological sample collected from a subject mayprovided in accordance with another aspect of the invention. The methodmay comprise: (a) receiving electronic data representative of an imageof said biological sample and/or chemical reaction performed with atleast one component from said biological sample transmitted from adevice placed in or on the subject or at a designated sample collectionsite, wherein the device is configured to process the biological sampleby: (i) receiving the biological sample; (ii) preparing the biologicalsample for a subsequent qualitative and/or quantitative evaluation,wherein said preparation yields the electronic data representative ofthe image of said biological sample and/or the chemical reaction; and(iii) transmitting the electronic data representative of the image to anauthorized analytical facility and/or an affiliate thereof; wherein theprocessing generates the electronic data representative of the imagenecessary for the subsequent qualitative and/or quantitative evaluationof said biological sample, and (b) analyzing the electronic datarepresentative of the image transmitted from the device, at theauthorized analytical facility and/or the affiliate thereof, to providesaid subsequent qualitative and/or quantitative evaluation of saidbiological sample.

Additional aspects may be directed to a method of evaluating abiological sample collected from a subject, said method comprising: (a)receiving data transmitted from a device placed in or on the subject orat a designated sample collection site, wherein the device is configuredto process the biological sample by (i) receiving the biological sample;(ii) preparing the biological sample for a subsequent qualitative and/orquantitative evaluation, to yield data necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample;and (iii) transmitting the data to a health care provider of anauthorized analytical facility and/or an affiliate thereof; and (b)analyzing the data transmitted from the device, at the authorizedanalytical facility and/or the affiliate thereof, to provide saidsubsequent qualitative and/or quantitative evaluation of said biologicalsample (c) verifying whether the subject received an order from a healthcare professional to undertake said subsequent qualitative and/orquantitative evaluation of said biological sample, wherein saidverifying step is performed prior to, concurrently with, or after steps(a) and/or (b).

Also, aspects of the invention may be directed to a method of evaluatinga biological sample, said method comprising: (a) processing, with aid ofa device, a biological sample collected from a subject having receivedan order for undertaking a subsequent qualitative and/or quantitativeevaluation of the biological sample, wherein the device is placed in oron the subject or at a designated sample collection site, wherein theprocessing generates data necessary for the subsequent qualitativeand/or quantitative evaluation of said biological sample, and whereinthe device is configured to (i) receive the biological sample; (ii)prepare the biological sample for a subsequent qualitative and/orquantitative evaluation; and (iii) transmit the data to an authorizedanalytical facility and/or an affiliate thereof; (b) transmitting thedata from the device, for analysis at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said biological sample; and (c)verifying whether the order for the subsequent qualitative and/orquantitative evaluation of said biological sample is within the policyrestrictions of a payer or a prescribing physician for said subsequentqualitative and/or quantitative evaluation, wherein said verifying stepis performed prior to, concurrently with, or after steps (a) and/or (b).

Another aspect of the invention provides a method of evaluating abiological sample collected from a subject, said method comprising: (a)receiving data transmitted from a device placed in or on the subject orat a designated sample collection site, wherein the device is configuredto process the biological sample by: (i) receiving the biologicalsample; (ii) preparing the biological sample for a subsequentqualitative and/or quantitative evaluation, to yield informationnecessary for the subsequent qualitative and/or quantitative evaluationof said biological sample; and (iii) transmitting electronically thedata to an authorized analytical facility and/or an affiliate thereof;and (b) analyzing the data transmitted from the device, at theauthorized analytical facility and/or the affiliate thereof, to providesaid subsequent qualitative and/or quantitative evaluation of saidbiological sample, wherein the subsequent qualitative and/orquantitative evaluation of said biological sample yields a determinationof the presence or concentration of an analyte selected from one or moreof the following: sodium, potassium, chloride, TCO₂, anion Gap, ionizedcalcium, glucose, urea nitrogen, creatinine, lactate, hematocrit,hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂, ACT Kaolin, ACTCelite, PT/INR, cTnl, CK-MB, or BNP.

Moreover, aspects of the invention may be directed to a method ofevaluating a plurality of types of biological samples collected from asubject, said method comprising: (a) receiving data transmitted from adevice placed in or on the subject or at a designated sample collectionsite, wherein the device is configured to process the plurality of typesof biological samples by: (i) receiving the plurality of types ofbiological samples; (ii) preparing the biological samples for asubsequent qualitative and/or quantitative evaluation, to yield datanecessary for the subsequent qualitative and/or quantitative evaluationof said plurality of types of biological samples; and (iii) transmittingelectronically the data to an authorized analytical facility and/or anaffiliate thereof; and (b) analyzing the data transmitted from thedevice, at the authorized analytical facility and/or the affiliatethereof, to provide said subsequent qualitative and/or quantitativeevaluation of said plurality of types of biological samples.

In practicing any of the methods above or elsewhere herein, alone or incombination, the qualitative and/or quantitative evaluation of saidbiological sample may be effected without transporting said sample fromthe site where the sample is collected to an authorized analyticalfacility and/or an affiliate thereof.

The methods above or elsewhere herein, alone or in combination, mayinclude methods wherein the biological sample is selected from the groupconsisting of blood, serum, plasma, nasal swab or nasopharyngeal wash,saliva, urine, tears, gastric fluid, spinal fluid, stool, mucus, sweat,earwax, oil, glandular secretion, cerebral spinal fluid, tissue, semen,and vaginal fluid, throat swab, breath, hair, finger nails, skin,biopsy, placental fluid, amniotic fluid, cord blood, emphatic fluids,cavity fluids, sputum, mucus, puss, micropiota, meconium, breast milkand/or other excretions.

Any of the methods above or elsewhere herein, alone or in combination,may be practiced wherein the biological sample has a volume of 250microliters (uL) or less.

In practicing the methods described above or elsewhere herein, alone orin combination, the methods may further comprise the step of providingoversight by a health care professional of the authorized analyticalfacility and/or by a software program.

In some embodiments, the methods above or elsewhere herein, alone or incombination may further comprising the step of verifying insuranceeligibility of said subject prior to, concurrent with or subsequent tosaid analysis.

The methods above or elsewhere herein, alone or in combination, mayfurther comprise generating a report that comprises the analysis forsaid subject based on said qualitative and/or quantitative evaluation.

In practicing the methods above or elsewhere herein, alone or incombination, the analysis may determine presence or concentration ofanalyte present in the biological sample.

The methods provided above or elsewhere herein, alone or in combination,may include an analyte selected from the group consisting of protein,nucleic acid, drug, drug metabolite, gas, ions, particles, smallmolecules and metabolites thereof, elements, toxins, lipids,carbohydrates, prions, formed elements, and combination thereof.

A designated sample collection site may be a retailer location or aphysician's office, in accordance with the practice of any of themethods described above or elsewhere herein, alone or in combination. Insome embodiments when practicing any of the methods described above orelsewhere herein, alone or in combination, the designated samplecollection site may be the subject's home. A designated samplecollection site may be an employer site, provider office, or hospital inmethods above or elsewhere herein, alone or in combination.

In practicing the methods above or elsewhere herein, alone or incombination, a further step may be provided of aggregating the data to ayield a longitudinal analysis over time.

The methods described above or elsewhere herein, alone or in combinationmay utilize a biological sample that is collected from a fingerstick.

In practicing the methods above or elsewhere herein, alone or incombination, in some instances, the processing of the biological sampledoes not involve a display of the presence or concentration level of oneor more analyte selected for determination of cardiac markers,chemistries, blood gases, electrolytes, lactate, hemoglobin, coagulationor hematology.

Methods described above or elsewhere herein, alone or in combination,may include a device that is configured to verify whether the subject iscovered by health insurance for said qualitative and/or quantitativeevaluation of the biological sample.

The device may be configured to verify whether the subject received anorder from a health care professional to undertake said qualitativeand/or quantitative evaluation of the biological sample, in the practiceof any of the methods above or elsewhere herein, alone or incombination.

In some embodiments, the methods above or elsewhere herein, alone or incombination, may include the device that is configured to verify thesubject's identity prior to receiving the biological sample,transmitting electronically the data, or analyzing the transmitted data.In some embodiments, the verification of the subject's identity maycomprise receiving a genetic signature of the subject. In some of themethods described above or elsewhere herein, alone or in combination,the genetic signature may be obtained by nucleic acid amplification of abiological sample from the subject. The verification of the subject'sidentity may comprise one or more biometric measurement of the subject,in the practice of the methods described above or elsewhere herein,alone or in combination. The verification of the subject's identity maybe performed by an authorized technician, in some embodiments of themethods described above or elsewhere herein, alone or in combination.

In practicing the methods above or elsewhere herein, alone or incombination, the identity of the authorized technician may be verifiedprior to receiving the biological sample, transmitting electronicallythe data, or analyzing the transmitted data.

The device may be configured to receive one or more cartridge configuredfor the qualitative and/or quantitative evaluation ordered by a healthcare professional, in the practice of one or more of the methods aboveor elsewhere herein, alone or in combination.

In some embodiments, one or more of the methods above or elsewhereherein, alone or in combination, may provide cartridge that has one ormore identifier that is readable by the device.

The methods above or elsewhere herein, alone or in combination, mayfurther comprise receiving the identifier information from the device.

The performance of methods above or elsewhere herein, alone or incombination may further comprise the step of providing one or moreprotocol to said device based on the identifier information received,wherein said protocol effects the preparation of the biological sample.

In practicing methods above or elsewhere herein, alone or incombination, the device may be contained within a housing.

Methods above or elsewhere herein, alone or in combination, may comprisea qualitative and/or quantitative evaluation that involves adetermination of clinical relevance of the biological sample or lackthereof.

The designated sample collection site may be a retailer location in thepractice of methods above or elsewhere herein, alone or in combination.In some embodiments of the invention, including methods above orelsewhere herein, alone or in combination, the designated samplecollection site is a chain store, pharmacy, supermarket, or departmentstore. The designated sample collection site may be the subject's homein methods above or elsewhere herein, alone or in combination.

The performance of methods above or elsewhere herein, alone or incombination may comprise data that includes electronic bitsrepresentative of the sample. The data may be aggregated and may beuseful for longitudinal analysis over time to facilitate diagnosis,treatment, and/or disease prevention in the methods above or elsewhereherein, alone or in combination.

The biological sample in the methods above or elsewhere herein, alone orin combination, may have a volume of 250 microliters (“uL”) or less. Insome embodiments, the biological sample may be blood, serum, saliva,urine, tears, gastric and/or digestive fluid, stool, mucus, sweat,earwax, oil, glandular secretion, semen, or vaginal fluid in the methodsabove or elsewhere herein, alone or in combination. In the practice ofmethods above or elsewhere herein, alone or in combination, thebiological sample may be a tissue sample. The methods above or elsewhereherein, alone or in combination, may include a biological sample that iscollected from a fingerstick.

Methods above or elsewhere herein, alone or in combination, may furthercomprise generating a report based on said qualitative and/orquantitative evaluation of said biological sample. In some embodiments,the performance of one or more methods above or elsewhere herein, aloneor in combination, may further comprise transmitting said report to anadditional health care professional. The additional health careprofessional may have provided the order to the subject to undertakesaid qualitative and/or quantitative evaluation of said biologicalsample in methods above or elsewhere herein, alone or in combination. Insome instances, the additional health care professional is at adifferent location from the authorized analytical facility in theperformance of methods above or elsewhere herein, alone or incombination.

In the practice of methods above or elsewhere herein, alone or incombination, processing may include adding one or more reagent orfixatives.

In some embodiments, the data is transmitted to a cloud computing basedinfrastructure in methods above or elsewhere herein, alone or incombination.

Methods above or elsewhere herein, alone or in combination, may comprisean image wherein the image is a video image. The data may compriseelectronic data representative of an image and/or audio signal in thepractice of methods above or elsewhere herein, alone or in combination.

In the practice of methods above or elsewhere herein, alone or incombination, a payer may receive an electronic bill from the designatedsample collection site.

A health care professional of the authorized analytical facility mayreceive an electronic payment from the designated sample collection sitein the practice of one methods above or elsewhere herein, alone or incombination.

The device utilized in methods above or elsewhere herein, alone or incombination, may be configured to additionally prepare the biologicalsample based on at least one of: prior preparation of the biologicalsample, analysis of the data at the authorized analytical facilityand/or the affiliate thereof.

In the performance of methods above or elsewhere herein, alone or incombination the authorized analytical facility may be separate from thesample collection site.

A preparation of a biological sample may be automated when practicingone or more of the methods above or elsewhere herein, alone or incombination.

Methods above or elsewhere herein, alone or in combination may furthercomprise overseeing said subsequent qualitative and/or quantitativeevaluation. The overseeing step may be performed by a health careprofessional of the authorized analytical facility and/or by a softwareprogram in methods above or elsewhere herein, alone or in combination.In some embodiments, transmitting the data from the device may also befor oversight of said subsequent qualitative and/or quantitativeevaluation in some methods above or elsewhere herein, alone or incombination. Methods above or elsewhere herein, alone or in combination,may be provided wherein the oversight is provided by the health careprofessional of the authorized analytical facility and/or by a softwareprogram.

The data utilized in methods above or elsewhere herein, alone or incombination, may be representative of the biological sample and/or anyportion thereof. In some embodiments, the data may be representative ofa preparation of the collected biological sample. The data may compriseinformation of one or more conditions under which a preparation of thecollected biological sample occurs. The one or more conditions maycomprise one or more characteristics listed from the group: amount ofthe biological sample, concentration of the biological sample, qualityof the biological sample, temperature, or humidity.

In some of the methods above or elsewhere herein, alone or incombination, the data is representative of a reaction run by the device.The data may comprise information of the rate of the reaction. In someinstances, the data may comprise information about a control reactionand a chemical reaction involving the biological sample.

In practicing methods above or elsewhere herein, alone or incombination, such methods may further comprise (c) overseeing one ormore steps of (i)-(iii) to improve quality of said evaluation, whereinsaid overseeing is performed prior to, concurrently with, or subsequentto any of steps (i)-(iii).

Methods above or elsewhere herein, alone or in combination may furthercomprise (iv) overseeing one or more steps of (i)-(iii) to improvequality of said evaluation, wherein said overseeing is performed priorto, concurrently with, or subsequent to any of steps (i)-(iii).

In some embodiments, methods above or elsewhere herein, alone or incombination may be provided wherein the overseeing is of datarepresentative of the biological sample and/or any portion thereof. Theoverseeing may be of data representative of the biological sample and/orany portion thereof. The overseeing may be of data representative of apreparation of the collected biological sample. In some instances, theoverseeing is of data representative of a preparation of the collectedbiological sample. The overseeing may be of information of one or moreconditions under which a preparation of the collected biological sampleoccurs. In methods above or elsewhere herein, alone or in combination,overseeing may be of information of one or more conditions under which apreparation of the collected biological sample occurs. The overseeingmay be of data that is representative of a chemical reaction run by thedevice. In some embodiments, overseeing may be of data is representativeof a chemical reaction run by the device.

In the performance of methods above or elsewhere herein, alone or incombination, the healthcare coverage may be provided by a healthinsurance company

Methods above or elsewhere herein, alone or in combination may comprisethe preparing step that involves one or more of the types of chemicalreactions selected from immunoassay, nucleic acid assay, receptor-basedassay, cytometric assay, colorimetric assay, enzymatic assay,electrophoretic assay, electrochemical assay, spectroscopic assay,chromatographic assay, microscopic assay, topographic assay,calorimetric assay, turbidmetric assay, agglutination assay,radioisotope assay, viscometric assay, coagulation assay, clotting timeassay, protein synthesis assay, histological assay, culture assay, orosmolarity assay.

The device may be further configured to process the biological sample bytransmitting electronically data representative of one or more biometricmeasurement of the subject, in accordance with methods above orelsewhere herein, alone or in combination.

In some methods above or elsewhere herein, alone or in combination, theprocessing of the biological sample does not encompass an analysis ofthe presence or concentration level of three or more analytes belongingto categories of cardiac marker, blood gas, electrolyte, lactate,hemoglobin, and coagulation factors.

In some embodiments, the processing of the biological sample does notencompass an analysis of the presence or concentration level of three ormore analytes belonging to the following: sodium, potassium, chloride,TCO₂, anion Gap, ionized calcium, glucose, urea nitrogen, creatinine,lactate, hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂,ACT Kaolin, ACT Celite, PT/INR, cTnl, CK-MB, and BNP, in the practice ofmethods above or elsewhere herein, alone or in combination.

In the practice of some methods above or elsewhere herein, alone or incombination, the sample collection site may be one or more of thefollowing: a hospital, clinic, military site, or subject's home.

In some embodiments, data may be displayed on the touch screen afteranalysis, for methods above or elsewhere herein, alone or incombination.

Methods above or elsewhere herein may include imaging data of body partsthat may be done for analysis simultaneously with biochemical analyses.

An aspect of the invention may be directed to a system of evaluating abiological sample collected from a subject, said system comprising: (a)a communication unit configured to receive data from a device placed inor on the subject or at a designated sample collection site, wherein thedevice is configured to process the biological sample, therebygenerating data necessary for a subsequent qualitative and/orquantitative evaluation of said biological sample, and wherein thedevice comprises (i) a sample collection unit configured to receive thebiological sample; (ii) a sample preparation unit configured to preparethe biological sample for the subsequent qualitative and/or quantitativeevaluation; and (iii) transmission unit configured to transmit the datato an authorized analytical facility and/or an affiliate thereof; and(b) a processor that processes said data for the qualitative and/orquantitative evaluation of said biological sample at the authorizedanalytical facility and/or the affiliate thereof, and wherein saidprocessor communicates with a record database comprising one or moremedical records and/or insurance information of the subject.

Additional aspects of the invention may be directed to a system ofevaluating a biological sample collected from a subject, said systemcomprising: (a) a communication unit configured to receive data from adevice placed in or on the subject or at a designated sample collectionsite, wherein the device is configured to process the biological sample,thereby generating data necessary for a subsequent qualitative and/orquantitative evaluation of said biological sample, and wherein thedevice comprises (i) a sample collection unit configured to receive thebiological sample; (ii) a sample preparation unit configured to preparethe biological sample for the subsequent qualitative and/or quantitativeevaluation; and (iii) transmission unit configured to transmit the datato an authorized analytical facility and/or an affiliate thereof; (b) aprocessor that processes said data for the subsequent qualitative and/orquantitative evaluation of said biological sample at the authorizedanalytical facility and/or the affiliate thereof, and wherein saidprocessor communicates with a record database comprising one or moremedical records for the subject, and/or wherein the processorcommunicates with a payer database comprising insurance information forthe subject.

In accordance with another aspect of the invention, a system ofevaluating a blood sample collected from a subject may be provided. Thesystem may comprise: (a) a communication unit configured to receive datafrom a device placed in or on the subject or at a designated samplecollection site, wherein the device is configured to process the bloodsample, thereby generating data necessary for a subsequent qualitativeand/or quantitative evaluation of said blood sample, and wherein thedevice comprises (i) a sample collection unit configured to receive theblood sample; (ii) a sample preparation unit configured to prepare thebiological sample for the subsequent qualitative and/or quantitativeevaluation, wherein the sample preparation unit permits at least onereagent to be added to the blood sample; and (iii) transmission unitconfigured to transmit the data to an authorized analytical facilityand/or an affiliate thereof; and (b) a processor that processes saiddata for the subsequent qualitative and/or quantitative evaluation ofsaid blood sample at the authorized analytical facility and/or theaffiliate thereof, and wherein said processor accesses a record databasecomprising one or more medical records for the subject, and/or whereinthe processor accesses a payer database comprising insurance informationfor the subject.

A system for rapid evaluation of a biological sample collected from asubject to aid in diagnosis, treatment, or prevention of a disease maybe provided in accordance with an additional aspect of the invention.The system may comprise: a communication unit for receiving from adevice electronic data representative of an image of said biologicalsample and/or a chemical reaction performed with at least one componentfrom said biological sample; said device being placed in or on thesubject or at a designated sample collection site, wherein said deviceis for processing the biological sample thereby generating theelectronic data representative of the image of said biological samplenecessary for a subsequent qualitative and/or quantitative evaluation ofsaid biological sample, and wherein the device comprises, within ahousing, (i) a sample collection unit for receiving the biologicalsample; (ii) a sample preparation unit for preparing the biologicalsample for the subsequent qualitative and/or quantitative evaluation,wherein the preparation of the biological sample is automated; (iii) animaging unit for recording an image of the biological sample and/or achemical reaction performed with at least one component from saidbiological sample; and (iv) a transmission unit for transmitting theelectronic data representative of the image and/or the chemicalreaction; and a processor that processes said electronic datarepresentative of the image for subsequent qualitative and/orquantitative evaluation of said biological sample.

In practicing the systems above or elsewhere herein, alone or incombination, the process may be configured to communicate with a payerdatabase comprising the insurance information for the subject.

The systems described above or elsewhere herein, alone or in combinationmay include a device that is configured to receive information relatingto said qualitative and/or quantitative evaluation and optionallydisplay said information on said device.

The device may comprises a processing unit configured to verify whetherthe subject is covered by health insurance for said qualitative and/orquantitative evaluation of the biological sample in the practice ofsystems above or elsewhere herein, alone or in combination.

In some embodiments, systems above or elsewhere herein, alone or incombination may comprise a device that is configured to verify whetherthe subject received an order from a health care professional toundertake said qualitative and/or quantitative evaluation of thebiological sample.

The processor provided in systems above or elsewhere herein, alone or incombination, may access the records database prior to providing saidqualitative and/or quantitative evaluation. Optionally, the processoraccesses the payer database prior to providing said qualitative and/orquantitative evaluation in systems above or elsewhere herein, alone orin combination.

Prior to providing said qualitative and/or quantitative evaluation, saidsystems above or elsewhere herein, alone or in combination, maydetermine which records database to access.

The device may be configured to receive one or more cartridge configuredfor the qualitative and/or quantitative evaluation ordered by a healthcare professional, in the practice of systems above or elsewhere herein,alone or in combination.

In some embodiments, the device is contained within a housing in systemsabove or elsewhere herein, alone or in combination.

In systems above or elsewhere herein, alone or in combination, thequalitative and/or quantitative evaluation may involve a determinationof clinical relevance of the biological sample or lack thereof.

The designated sample collection site may be a chain store, pharmacy,supermarket, or department store in systems above or elsewhere herein,alone or in combination. In some embodiments, the designated samplecollection site is the subject's home.

The systems above or elsewhere herein, alone or in combination, maycomprise a biological sample that has a volume of 250 uL or less. Thebiological sample may be blood, serum, saliva, urine, tears, gastricand/or digestive fluid, stool, mucus, sweat, earwax, oil, glandularsecretion, semen, or vaginal fluid. In some instances, the biologicalsample may be a tissue sample.

In some systems above or elsewhere herein, alone or in combination, thebiological sample may be collected from a fingerstick.

In some embodiments, systems above or elsewhere herein may utilize adesignated sample collection site that may be a retailer. A designatedsample collection site may be an employer site, provider office, orhospital in systems above or elsewhere herein, alone or in combination.

An authorized analytical facility, in some systems above or elsewhereherein, alone or in combination, may be separate from the samplecollection site.

A user interface may be accessible by a health care professional forsaid subsequent qualitative and/or quantitative evaluation and/oroversight of said subsequent qualitative and/or quantitative evaluationin systems above or elsewhere herein, alone or in combination.

In systems above or elsewhere herein, alone or in combination, aprocessor may further provide oversight of said subsequent qualitativeand/or quantitative evaluation.

A sample preparation unit may comprise (i) a pipette, and optionally(ii) one or more of the following: centrifuge, magnetic separator,filter, vessels, containers, assay units, reagent units, heater, thermalcontroller, cytometer, electromagnetic source, temperature sensor,motion sensor, or sensor for electrical properties, in systems above orelsewhere herein, alone or in combination.

In some embodiments, systems above or elsewhere herein, alone or incombination may comprise an image. The image may be static. In someembodiments, the image may be a video image. Systems above or elsewhereherein, alone or in combination may include the transmission unit thatis configured to transmit the electronic data representative of theimage wirelessly.

In systems above or elsewhere herein, alone or in combination, data maycomprise electronic data representative of the image and an audiosignal.

A device in systems above or elsewhere herein, alone or in combination,may be configured to receive one or more cartridge configured for thequalitative and/or quantitative evaluation. In some embodiments, thecartridge may have one or more identifier that is readable by thedevice.

In some systems above or elsewhere herein, alone or in combination, atleast one component may be a biological analyte made of carbohydrate,lipid, protein or a combination thereof.

In utilizing the systems above or elsewhere herein, alone or incombination, a chemical reaction may be performed without the biologicalsample.

In some embodiments, data may be displayed on the touch screen afteranalysis, for systems above or elsewhere herein, alone or incombination.

Systems above or elsewhere herein may include imaging data of body partsthat may be done for analysis simultaneously with biochemical analyses.

Some aspects of the invention are directed to a method of performing apathological study of a biological sample collected from a subject, saidmethod comprising (a) receiving electronic data representative of animage of said biological sample and/or a chemical reaction performedwith at least one component of the biological sample from a deviceplaced in or on the subject or at a designated sample collection site,wherein the device is configured to: (i) receive said biological sample;(ii) prepare the collected biological sample for a subsequentqualitative and/or quantitative evaluation, wherein said preparationyields the electronic data representative of the image of saidbiological sample and/or the chemical reaction; and (iii) transmit theelectronic data representative of the image to a pathologist of anauthorized analytical facility; and (b) analyzing the electronic data bythe pathologist of the authorized analytical facility to provide saidsubsequent qualitative and/or quantitative evaluation.

An aspect of the invention is directed to a method of evaluating abiological sample collected from a subject. The method comprises (a)receiving data transmitted from a device placed in or on the subject orat a designated sample collection site, wherein the device is configuredto process the biological sample by: (i) receiving the biologicalsample; (ii) preparing the biological sample for a subsequentqualitative and/or quantitative evaluation, to yield data necessary forthe subsequent qualitative and/or quantitative evaluation of saidbiological sample; and (iii) transmitting electronically the data to anauthorized analytical facility and/or an affiliate thereof; and (b)analyzing the data transmitted from the device, at the authorizedanalytical facility and/or the affiliate thereof, to provide saidsubsequent qualitative and/or quantitative evaluation of said biologicalsample. This may be in contrast to conventional devices which may onlytransmit results of an analysis, not data for subsequent qualitativeand/or quantitative evaluation of a sample. Such conventional devicesthat only transmit results may not be relied upon by one or more healthcare professional in diagnosing, treating and/or preventing a diseasefor subject.

In some embodiments, the processing of the biological sample does notencompass an analysis of the presence or concentration level of three ormore analytes belonging to categories of cardiac marker, blood gas,electrolyte, lactate, hemoglobin, and coagulation factors. In someinstances, the processing of the biological sample does not encompass ananalysis of the presence or concentration level of three or moreanalytes belonging to the following: sodium, potassium, chloride, TCO₂,anion Gap, ionized calcium, glucose, urea nitrogen, creatinine, lactate,hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂, ACTKaolin, ACT Celite, PT/INR, cTnl, CK-MB, and BNP.

A method of evaluating a biological sample collected from a subject isprovided in accordance with another aspect of the invention. The methodcomprises (a) receiving data transmitted from a device placed in or onthe subject or at a retailer site, wherein the device is configured toprocess the biological sample by: (i) receiving the biological sample;(ii) preparing the biological sample for a subsequent qualitative and/orquantitative evaluation, to yield data necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample;and (iii) transmitting electronically the data to an authorizedanalytical facility and/or an affiliate thereof; and (b) analyzing thedata transmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said biological sample.

An additional aspect of the invention is a method of evaluating abiological sample, said method comprising: (a) processing, with the aidof a device, a biological sample collected from a subject, wherein thedevice is placed in or on the subject or at a designated samplecollection site, wherein the processing generates data necessary for asubsequent qualitative and/or quantitative evaluation of said biologicalsample, and wherein the device is configured to (i) receive thebiological sample; (ii) prepare the biological sample for the subsequentqualitative and/or quantitative evaluation; and (iii) transmit the datato an authorized analytical facility and/or an affiliate thereof; (b)transmitting the data from the device, at the authorized analyticalfacility and/or the affiliate thereof, to provide said subsequentqualitative and/or quantitative evaluation of said biological sample;and (c) verifying whether the subject has healthcare coverage, whereinsaid verifying step is performed prior to, concurrently with, or aftersteps (a) and/or (b).

Another aspect of the invention is a method of evaluating a biologicalsample collected from a subject, said method comprising (a) receivingelectronic data representative of an image of said biological sampleand/or chemical reaction performed on a device, wherein the electronicdata is transmitted from a device placed in or on the subject or at adesignated sample collection site, wherein the device is configured toprocess the biological sample by: (i) receiving the biological sample;(ii) preparing the biological sample for a subsequent qualitative and/orquantitative evaluation, wherein said preparation yields the electronicdata representative of the image of said biological sample and/or thechemical reaction; and (iii) transmitting the electronic datarepresentative of the image to an authorized analytical facility and/oran affiliate thereof; wherein the processing generates the electronicdata representative of the image necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample;and (b) analyzing the electronic data representative of the imagetransmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said biological sample.

A system of evaluating a biological sample collected from a subject isprovided in accordance with yet another aspect of the invention. Thesystem comprises (a) a communication unit configured to receive datafrom a device placed in or on the subject or at a designated samplecollection site, wherein the device is configured to process thebiological sample, thereby generating data necessary for a subsequentqualitative and/or quantitative evaluation of said biological sample,and wherein the device comprises (i) a sample collection unit configuredto receive the biological sample; (ii) a sample preparation unitconfigured to prepare the biological sample for the subsequentqualitative and/or quantitative evaluation; and (iii) transmission unitconfigured to transmit the data to an authorized analytical facilityand/or an affiliate thereof; (b) a processor that processes said datafor the subsequent qualitative and/or quantitative evaluation of saidbiological sample at the authorized analytical facility and/or theaffiliate thereof, and wherein said processor communicates with a recorddatabase comprising one or more medical records for the subject, and/orwherein the processor communicates with a payer database comprisinginsurance information for the subject.

Furthermore, a method of evaluating a biological sample collected from asubject is provided. The method comprises (a) receiving data transmittedfrom a device placed in or on the subject or at a designated samplecollection site, wherein the device is configured to process thebiological sample by (i) receiving the biological sample; (ii) preparingthe biological sample for a subsequent qualitative and/or quantitativeevaluation, to yield data necessary for the subsequent qualitativeand/or quantitative evaluation of said biological sample; and (iii)transmitting the data to a health care provider of an authorizedanalytical facility and/or an affiliate thereof; and (b) analyzing thedata transmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said biological sample; and (c)verifying whether the subject received an order from a health careprofessional to undertake said subsequent qualitative and/orquantitative evaluation of said biological sample, wherein saidverifying step is performed prior to, concurrently with, or after steps(a) and/or (b).

An additional aspect of the invention is directed to a method ofevaluating a biological sample, said method comprising (a) processing,with aid of a device, a biological sample collected from a subjecthaving received an order for undertaking a subsequent qualitative and/orquantitative evaluation of the biological sample, wherein the device isplaced in or on the subject or at a designated sample collection site,wherein the processing generates data necessary for the subsequentqualitative and/or quantitative evaluation of said biological sample,and wherein the device is configured to (i) receive the biologicalsample; (ii) prepare the biological sample for a subsequent qualitativeand/or quantitative evaluation; and (iii) transmit the data to anauthorized analytical facility and/or an affiliate thereof; (b)transmitting the data from the device, for analysis at the authorizedanalytical facility and/or the affiliate thereof, to provide saidsubsequent qualitative and/or quantitative evaluation of said biologicalsample; and (c) verifying whether the order for the subsequentqualitative and/or quantitative evaluation of said biological sample iswithin the policy restrictions of a payer or a prescribing physician forsaid subsequent qualitative and/or quantitative evaluation, wherein saidverifying step is performed prior to, concurrently with, or after steps(a) and/or (b).

A method of evaluating a biological sample collected from a subject isillustrated in accordance with an aspect of the invention. The methodcomprises (a) receiving data transmitted from a device placed in or onthe subject or at a designated sample collection site, wherein thedevice is configured to process the biological sample by (i) receivingthe biological sample; (ii) preparing the biological sample for asubsequent qualitative and/or quantitative evaluation, to yieldinformation necessary for the subsequent qualitative and/or quantitativeevaluation of said biological sample; and (iii) transmittingelectronically the data to an authorized analytical facility and/or anaffiliate thereof; and (b) analyzing the data transmitted from thedevice, at the authorized analytical facility and/or the affiliatethereof, to provide said subsequent qualitative and/or quantitativeevaluation of said biological sample, wherein the subsequent qualitativeand/or quantitative evaluation of said biological sample yields adetermination of the presence or concentration of an analyte belongingselected from one or more of the following: sodium, potassium, chloride,TCO₂, anion Gap, ionized calcium, glucose, urea nitrogen, creatinine,lactate, hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂,ACT Kaolin, ACT Celite, PT/INR, cTnl, CK-MB, or BNP.

In another aspect, the invention provides a system of evaluating a bloodsample collected from a subject, said system comprising (a) acommunication unit configured to receive data from a device placed in oron the subject or at a designated sample collection site, wherein thedevice is configured to process the blood sample, thereby generatingdata necessary for a subsequent qualitative and/or quantitativeevaluation of said blood sample, and wherein the device comprises (i) asample collection unit configured to receive the blood sample; (ii) asample preparation unit configured to prepare the biological sample forthe subsequent qualitative and/or quantitative evaluation, wherein thesample preparation unit permits at least one reagent to be added to theblood sample; and (iii) transmission unit configured to transmit thedata to an authorized analytical facility and/or an affiliate thereof;and (b) a processor that processes said data for the subsequentqualitative and/or quantitative evaluation of said blood sample at theauthorized analytical facility and/or the affiliate thereof, and whereinsaid processor accesses a record database comprising one or more medicalrecords for the subject, and/or wherein the processor accesses a payerdatabase comprising insurance information for the subject.

Another method of evaluating a plurality of types of biological samplescollected from a subject is provided. The method comprises (a) receivingdata transmitted from a device placed in or on the subject or at adesignated sample collection site, wherein the device is configured toprocess the plurality of types of biological samples by (i) receivingthe plurality of types of biological samples; (ii) preparing thebiological samples for a subsequent qualitative and/or quantitativeevaluation, to yield data necessary for the subsequent qualitativeand/or quantitative evaluation of said plurality of types of biologicalsamples; and (iii) transmitting electronically the data to an authorizedanalytical facility and/or an affiliate thereof; and (b) analyzing thedata transmitted from the device, at the authorized analytical facilityand/or the affiliate thereof, to provide said subsequent qualitativeand/or quantitative evaluation of said plurality of types of biologicalsamples.

In some embodiments, the processing of the biological sample does notinvolve a display of the presence or concentration level of one or moreanalyte selected for determination of cardiac markers, chemistries,blood gases, electrolytes, lactate, hemoglobin, coagulation orhematology. In some embodiments, the processing of the biological sampledoes not involve a display of the presence or concentration level ofthree or more analytes belonging to the following: sodium, potassium,chloride, TCO₂, anion Gap, ionized calcium, glucose, urea nitrogen,creatinine, lactate, hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, baseexcess, sO₂, ACT Kaolin, ACT Celite, PT/INR, cTnl, CK-MB, and BNP. Afterthe subsequent analysis, such information can be transmitted back to thedevice, such as for display, storage, or analysis.

Furthermore, in some embodiments, the device is configured to verifywhether the subject is covered by health insurance for said qualitativeand/or quantitative evaluation of the biological sample. The device cancomprise a processing unit configured to verify whether the subject iscovered by health insurance for said qualitative and/or quantitativeevaluation of the biological sample. The device can be configured toverify whether the subject received an order from a health careprofessional to undertake said qualitative and/or quantitativeevaluation of the biological sample.

In some instances, the processor accesses the records database prior toproviding said qualitative and/or quantitative evaluation. The processormay access the payer database prior to providing said qualitative and/orquantitative evaluation. In some embodiments, prior to providing saidqualitative and/or quantitative evaluation, said system determines whichrecords database to access.

In some embodiments, the device is configured to verify the subject'sidentity prior to receiving the biological sample, transmittingelectronically the data, or analyzing the transmitted data. Theverification of the subject's identity can comprise receiving a geneticsignature of the subject. The genetic signature can be obtained bynucleic acid amplification of a biological sample from the subject. Theverification of the subject's identity can comprise one or morebiometric measurement of the subject. The verification of the subject'sidentity can be performed by an authorized technician. The identity ofthe authorized technician can be verified prior to receiving thebiological sample, transmitting electronically the data, or analyzingthe transmitted data.

In accordance with some embodiments of the invention, the device can beconfigured to receive one or more cartridge configured for thequalitative and/or quantitative evaluation ordered by a health careprofessional. The device can be configured to receive one or morecartridge configured for the qualitative and/or quantitative evaluationordered by a health care professional. The cartridge can have one ormore identifier that is readable by the device. In some instances,methods are provided further comprising receiving the identifierinformation from the device. Such methods can also further compriseproviding one or more protocol to said device based on the identifierinformation received, wherein said protocol effects the preparation ofthe biological sample. A protocol may be provided from a serverwirelessly to facilitate preparation and/or processing of the biologicalsample. The protocol may be provided from the cloud or from any externaldevice.

In some embodiments, the device is contained within a housing.

The qualitative and/or quantitative evaluation can involve adetermination of clinical relevance of the biological sample or lackthereof.

The designated sample collection site is a retailer location in someembodiments of the invention. The designated sample collection site canbe a chain store, pharmacy, supermarket, or department store. Thedesignated sample collection site can be the subject's home.

In some embodiments, the data includes electronic bits representative ofthe sample. The data can be aggregated and is useful for longitudinalanalysis over time to facilitate diagnosis, progress treatment, and/ordisease prevention. The data can also be useful and viewable forlongitudinal analysis over time to facilitate diagnosis, progresstreatment, and/or disease prevention, as well as a better understandingof disease progression or regression, or efficacy of an intervention,including a treatment or lifestyle change.

The biological sample can have a volume of 250 uL or less. Thebiological sample is blood, serum, saliva, urine, tears, gastric and/ordigestive fluid, stool, mucus, sweat, earwax, oil, glandular secretion,semen, or vaginal fluid. The biological sample can be a tissue sample.The biological sample can be collected from a fingerstick.

In some embodiments, a method can further comprise generating a reportbased on said qualitative and/or quantitative evaluation of saidbiological sample. The method can further comprise transmitting saidreport to an additional health care professional. In some instances, theadditional health care professional provided the order to the subject toundertake said qualitative and/or quantitative evaluation of saidbiological sample. The additional health care professional can be at adifferent location from the authorized analytical facility.

In some embodiments, processing includes adding one or more reagent orfixatives.

The data can be transmitted to a cloud computing based infrastructure inaccordance with an embodiment of the invention. The image can be a videoimage. The data can comprise electronic data representative of an imageand/or audio signal. The cloud computing based infrastructure may beself learning. Data may be provided to a model that may refit and retunebased on the data that is collected. The cloud computing basedinfrastructure can perform the analysis.

In some embodiments, the processor accesses the payer database. A payercan receive an electronic bill from the designated sample collectionsite. A health care professional of the authorized analytical facilitycan receive an electronic payment from the designated sample collectionsite.

The device can be configured to additionally prepare the biologicalsample based on at least one of: prior preparation of the biologicalsample, analysis of the data at the authorized analytical facilityand/or the affiliate thereof.

In some embodiments, the authorized analytical facility is separate fromthe sample collection site.

The preparation of the biological sample can be automated.

Methods may be provided further comprising overseeing said subsequentqualitative and/or quantitative evaluation. The overseeing step can beperformed by a health care professional of the authorized analyticalfacility and/or by a software program. Transmitting the data from thedevice can also be for oversight of said subsequent qualitative and/orquantitative evaluation. The oversight can be provided by the healthcare professional of the authorized analytical facility and/or by asoftware program. A user interface can be provided accessible by ahealth care professional for said subsequent qualitative and/orquantitative evaluation and/or oversight of said subsequent qualitativeand/or quantitative evaluation. The processor can further provideoversight of said subsequent qualitative and/or quantitative evaluation.

In some embodiments, the data is representative of the biological sampleand/or any portion thereof. The data can be representative of apreparation of the collected biological sample. The data can compriseinformation of one or more conditions under which a preparation of thecollected biological sample occurs. One or more conditions can compriseone or more characteristics listed from the group: amount of thebiological sample, concentration of the biological sample, quality ofthe biological sample, temperature, or humidity. The data can berepresentative of a reaction run by the device. The data can compriseinformation of the rate, quality, and/or performance of the reaction.The data can comprise information about a control reaction and achemical reaction involving the biological sample. Collected data can bea photon as a result of a chemical reaction. Other examples of data mayinclude electrons, photons, intensities, frequencies, colors, sounds, ortemperatures.

In some embodiments, methods are provided further comprising (c)overseeing one or more steps of (i)-(iii) to improve quality of saidevaluation, wherein said overseeing is performed prior to, concurrentlywith, or subsequent to any of steps (i)-(iii). Additionally methods areprovided further comprising (iv) overseeing one or more steps of(i)-(iii) to improve quality of said evaluation, wherein said overseeingis performed prior to, concurrently with, or subsequent to any of steps(i)-(iii). The overseeing can be of data that is representative of thebiological sample and/or any portion thereof. The overseeing can be ofdata that is representative of a preparation of the collected biologicalsample. The overseeing can be of information of one or more conditionsunder which a preparation of the collected biological sample occurs. Theoverseeing can be of that is data representative of a reaction run bythe device. The overseeing can be of data that is representative of areaction run that occurs within the system.

In some embodiments, healthcare coverage is provided by a healthinsurance company and/or employer.

In some embodiments, a preparing step involves one or more of the typesof reactions selected from immunoassay, nucleic acid assay,receptor-based assay, cytometry, colorimetric assay, enzymatic assay,spectroscopic assay (e.g., mass spectrometry, infrared spectroscopy,x-ray photoelectron spectroscopy), electrophoresis, nucleic acidsequencing, agglutination, chromatography, coagulation, electrochemicalassay, histology, or cell analysis, including dead and/or live cellanalysis, molecular biology, chemistry, turbidmetric assay,agglutination assay, radioisotope assay, viscometric assay, coagulationassay, clotting time assay, protein synthesis assay, histological assay,culture assay, osmolarity assay, microscopic assay, topographic assay,calorimetric assay, and/or other types of assays or combinationsthereof.

The device can be further configured to process the biological sample bytransmitting electronically data representative of one or more biometricmeasurements of the subject.

In some embodiments, a sample collection site is one or more of thefollowing: a hospital, clinic, emergency room, military site, orsubject's home.

An aspect of the invention may be directed to a system for rapidevaluation of a biological sample collected from a subject to aid indiagnosis, treatment, or prevention of a disease, said systemcomprising: a communication unit for receiving from a device electronicdata representative of an image of said biological sample and/or achemical reaction performed with at least one component from saidbiological sample; said device being placed in or on the subject or at adesignated sample collection site, wherein said device is for processingthe biological sample thereby generating the electronic datarepresentative of the image of said biological sample necessary for asubsequent qualitative and/or quantitative evaluation of said biologicalsample, and wherein the device comprises, within a housing, (i) a samplecollection unit for receiving the biological sample; (ii) a samplepreparation unit for preparing the biological sample for the subsequentqualitative and/or quantitative evaluation, wherein the preparation ofthe biological sample is automated; (iii) an imaging unit for recordingan image of the biological sample and/or a chemical reaction performedwith at least one component from said biological sample; and (iv) atransmission unit for transmitting the electronic data representative ofthe image and/or the chemical reaction; and a processor that processessaid electronic data representative of the image for subsequentqualitative and/or quantitative evaluation of said biological sample.

In some embodiments, the sample preparation unit may comprise (i) apipette, and optionally (ii) one or more of the following: centrifuge,magnetic separator, filter, vessels, containers, assay units, reagentunits, heater, thermal controller, cytometer, electromagnetic source,temperature sensor, motion sensor, or sensor for electrical properties.

The image may be static and/or a video image. The data may compriseelectronic data representative of the image and an audio signal.

The biological sample may be selected from one or more of the following:blood, serum, saliva, urine, tears, gastric and/or digestive fluid,stool, mucus, sweat, earwax, oil, glandular secretion, semen, or vaginalfluid. In some embodiments, the biological sample has a volume of 250 uLor less. A component of a biological sample may be a biological analytemade of carbohydrate, lipid, protein or a combination thereof. Achemical reaction may be performed without the biological sample.

The transmission unit may be configured to transmit the electronic datarepresentative of the image wirelessly.

The device may be configured to receive one or more cartridge configuredfor the qualitative and/or quantitative evaluation. In some embodiments,the cartridge may have one or more identifier that is readable by thedevice.

Other goals and advantages of the invention will be further appreciatedand understood when considered in conjunction with the followingdescription and accompanying drawings. While the following descriptionmay contain specific details describing particular embodiments of theinvention, this should not be construed as limitations to the scope ofthe invention but rather as an exemplification of preferableembodiments. For each aspect of the invention, many variations arepossible as suggested herein that are known to those of ordinary skillin the art. A variety of changes and modifications can be made withinthe scope of the invention without departing from the spirit thereof.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A shows an operation scheme involving a laboratory, a samplecollection site, and a health care professional.

FIG. 1B shows a retailer having a processing device in communicationwith a laboratory (e.g. a CLIA certified laboratory).

FIG. 2 shows a processing device that can be placed in a designatedsample collection site and is configured to be in communication over anetwork with one or more other devices.

FIG. 3A illustrates various exemplary components of a processing device.

FIG. 3B illustrates another example of a device.

FIG. 4 shows an example of a sample collection, processing, and analysismethod.

FIG. 5 shows a laboratory benefit manager in communication with a payerand a sample collection site.

FIG. 6 shows a laboratory benefit system provided in accordance with anembodiment of the invention.

FIG. 7 shows an example of a laboratory benefit manager/wholesaler modelin accordance with an embodiment of the invention.

FIG. 8 shows examples of a system providing sample processing, analysis,and oversight.

FIG. 9 shows exemplary assays and tests.

DETAILED DESCRIPTION OF THE INVENTION

While preferable embodiments of the invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention.

The invention provides systems and methods for collecting andtransmitting data relating to a sample, and often representative of thesample so that further analysis of the sample does not require physicaltransportation of the sample. Various aspects of the invention describedherein may be applied to any of the particular applications set forthbelow or for any other types of diagnostic or assay systems. Theinvention may be applied as a standalone system or method, or as part ofan integrated system, such as in a system between laboratories, healthcare professionals, and sample collection sites. It shall be understoodthat different aspects of the invention can be appreciated individually,collectively, or in combination with each other.

FIG. 1A shows a system comprising a laboratory 110, a designated samplecollection site 120, and a health care professional 100. A device 130may be provided at the designated sample collection site. A samplecollection site may be a first location, and a laboratory may beprovided at a second location. The first location and the secondlocation may be different locations. The first and second locations maybe located so that they are not proximate to one another. A health careprofessional may be provided at a third location, although he/she may beaffiliated with, employed by, or contracted by the laboratory. The thirdlocation may be a different location from the first and secondlocations. The third location may be located so that it is not proximateto the first or second locations. A laboratory, health careprofessional, and sample collection site may all be at differentlocations from one another. In one example, a laboratory, health careprofessional, and/or sample collection site may be at separatefacilities. Alternatively, one or more of them may be at the samelocation.

A laboratory can be an entity or facility or system or device capable ofperforming a clinical test or analyzing collected data. A laboratory canprovide controlled conditions in which scientific research, experiments,and measurement can be performed. The laboratory can be a medicallaboratory or clinical laboratory where tests can be done on clinicalspecimens, or analysis can occur on data collected from clinicalspecimens, in order to get information about the health of a patient aspertaining to the diagnosis, prognosis, treatment, and/or prevention ofdisease. A clinical specimen may be a sample collected from a subject.Preferably, a clinical specimen may be collected from the subject at asample collection site that is at a separate facility from thelaboratory, as described in further detail elsewhere herein. Theclinical specimen may be collected from the subject using a device,which is placed at a designated sample collection site or in or on thesubject.

In some embodiments, a laboratory may be a certified laboratory. Thecertified laboratory may be an authorized analytical facility. In someembodiments, authorized analytical facilities may include contractedanalytical facilities. For example, a certified laboratory or otherlaboratory may send images to experts at another laboratory (which maybe a certified laboratory) for analysis.

Any description herein of a laboratory may apply to an authorizedanalytical facility and vice versa. In some instances, the laboratorymay be certified by a governmental agency or professional association. Alaboratory may receive certification or oversight by a regulatory body.In one example, the laboratory may be certified by an entity, such asCenters for Medicare & Medicaid Services (CMS), College of AmericanPathologists, ISO standards 15189 or 17025 or equivalents thereof. Forinstance, an authorized analytical facility may be a Clinical LaboratoryImprovement Amendments (CLIA) certified laboratory in the United Statesor its equivalent in a foreign jurisdiction.

An authorized analytical facility is typically subject to oversight orregulation. For example, a laboratory may have oversight by aboard-certified entity (which may include one or more board-certifiedpersonnel). In some embodiments, oversight can include validating one ormore clinical test. Oversight may also include assessing the performanceof, correcting, calibrating, running controls, replicates, adjusting, oranalyzing one or more clinical test. Oversight can include evaluation ofone or more sets of data to provide a quality control for a clinicaltest. The authorized analytical facility can have one or more qualifiedperson providing the oversight. For example, one or more pathologist orother health care professional may review data and/or analysis that isprocessed by the facility. At an authorized analytical facility, atrained pathologist or other certified health care professional mayprovide oversight. In some instances, the certified health careprofessional providing oversight may be one or more of the following: adoctor certified in pathology, a doctor with laboratory training orexperience in the specialty areas of service for which the health careprofessional is responsible, or an individual with experience orlaboratory training in the specialty.

The oversight may further include the certified health care professionalwho may establish the procedures and rules in the laboratory, deal withproblems that arise, and/or train/evaluate the lab personnel. Oversightmay also include selecting test methodology, verifying test proceduresand establishment of laboratory's test performance characteristics,enrollment in participation in an HHS approved proficiency testingprogram, establishing a quality control program appropriate for thetesting performed, establishing the parameters for acceptable levels ofanalytic performance, ensuring that those levels are maintainedthroughout the entire testing process, resolving technical problems andensuring that remedial actions are taken when test systems deviate fromthe established performance specifications, ensuring patient testresults are not reported until all corrective actions have been taken,identifying training needs and assuring that each individual performingtests receives regular in-service training and education, evaluating thecompetency of all testing personnel and assuring that the staff maintaintheir competency to perform test procedures (e.g., also procedures forevaluation of the staff: direct observation of routine test performance,monitoring the recording/reporting of results, review of intermediatetest results, records, etc., observation of performance of instrumentmaintenance, assessment of test performance, assessment of problemsolving skills), and/or evaluating and documenting the performance ofindividuals responsible for moderate complexity testing (e.g.,semiannually during the first year; thereafter, at least annually unlesstest methodology or instrumentation changes). Oversight may includereviewing and/or verifying functionality of laboratory procedures ordevices, and/or validity of data collected and/or generated. Theoversight may assure the quality of the rest and/or put the data into acondition upon which a health care professional can rely upon it toprovide a diagnosis, treatment, including but not limited toprophylactic treatment. Oversight may include reviewing a testempirically. Oversight may include one or more, two or more, or any ofthe number of items described elsewhere herein.

In some instances, the oversight may be provided by an oversightsoftware program rather than the certified health care professional. Insome instances, one, two or more of the types of oversight provided maybe implemented by an oversight software program. A combination of anoversight software program and health care professional may be employedto provide oversight. In some instances, one, two or more of the typesof oversight may be implemented by a health care professional over asoftware program. For example, the health care professional maydetermine the procedures and rules associated with the software program.In some instances, the software program may be self-learning. Thesoftware program may access an increasing pool of data and/or evolvingrules or procedures.

In some embodiments, the oversight software program may be provided on adevice. The oversight software program may be provided at a samplecollection site, on or off the device. The software program may beprovided a laboratory, such as an authorized analytical facility. Insome instances, the device may receive updates to the oversight softwareprogram. The updates may or may not be provided by the laboratory. Theoversight software may be stored in a memory, and may include computerreadable media comprising code, instructions, or logics that may becapable of executing a step.

In some instances, the oversight software may include one or morealgorithm that may review a qualitative and/or quantitative evaluationof the sample that may be performed. The oversight software program maylook for outliers, may determine whether the qualitative and/orquantitative evaluation was properly performed, may perform one or morecomparison with records or data points, may perform statistical analysisof the evaluation, or any other oversight action as described elsewhereherein. The oversight software may be able to perform one or morecalibrations and/or diagnostics.

A health care professional of an authorized analytical facility mayreceive and/or view data. A health care professional of an authorizedanalytical facility may be affiliated with or associated with theauthorized analytical facility. In some instances, the health careprofessional may be employed by or under contract with the authorizedanalytical facility. The health care professional may be located at theauthorized analytical facility, may be located remotely from theauthorized analytical facility, or in another analytical facility (e.g.,hospital, center of excellence, specialized leading path/group). In someinstances, the health care professional is not required to be on-site atall times while testing is performed, or when data is received at anauthorized analytical facility, but may be available on an as neededbasis to provide consultation. The health care professional may beaccessible to provide on-site, telephone and/or electronic consultation.

The health care professional providing oversight may be a differentindividual from or the same individual as the health care professionalthat may receive a report from the authorized analytical facility fordiagnosing, treating, monitoring, or preventing a disease for thesubject. For example, a pathologist of an authorized analytical facilitymay be a different individual from a prescribing physician of thesubject. A health care professional of authorized analytical facilitymay be a reviewing health care professional or an overseeing health careprofessional. The health care professional who may receive the reportmay be the health care professional who has ordered the test that thesubject has undertaken. A different health care professional may provideanalysis, and a different health care professional may provideoversight. Alternatively, the same health care professional may provideboth analysis and oversight.

A designated sample collection site may be a point of service (POS)location. Any disclosure herein of a sample collection site may alsoapply to a point of service location and vice versa. A point of servicelocation where a sample may be collected from a subject or provided by asubject may be a location remote to the laboratory. The samplecollection site may have a separate facility from a laboratory. Thesample may or may not be collected fresh from the subject at the samplecollection site. Alternatively, the sample may be collected from thesubject elsewhere and brought to the sample collection site. A samplecollection site at a point of service location may be a blood collectioncenter, or any other bodily fluid collection center. The samplecollection site may be a biological sample collection center. In someembodiments, a sample collection site may be a retailer. Examples ofretailers are provided in further detail elsewhere herein. Otherexamples of sample collection sites may include hospitals, clinics,health care professionals' offices, schools, day-care centers, healthcenters, assisted living residences, government offices, travelingmedical care units, mobile units, emergency vehicles (e.g., air, boat,ambulance), or the home. For example, a sample collection site may be asubject's home. A sample collection site may be at a sample acquisitionsite and/or health assessment and/or treatment locations (which mayinclude any of the sample collection sites described elsewhere hereinincluding but not limited to emergency rooms, doctors' offices, urgentcare, tents for screening (which may be in remote locations), a healthcare professional walking into someone's house to provide home care). Asample collection site may be any location where a sample from thesubject is received by the device. Any location may be designated as asample collection site. The designation may be made by any party,including but not limited to the laboratory, entity associated with thelaboratory, governmental agency, or regulatory body. Any descriptionherein relating to sample collection site or point of service may relateto or be applied to retailers, hospitals, clinics, or any other examplesprovided herein and vice versa.

A device may be provided at the sample collection site. The device maybe configured to accept a sample. The device may be referred to as asample collection device. The device may also be referred to as a sampleprocessing device. The device may also be referred to as a readerdevice. Any description of a reader device may apply to any device thatmay be capable of receiving a sample and/or processing the sample. Thedevice may accept a sample collected from a subject at the samplecollection site, or that the subject or subject's proxy brings to theservice location. The device may directly collect the sample from thesubject, or an intermediate device or technique may be used to collectthe sample from the subject. Examples of collection techniques andmechanisms are described in greater detail elsewhere herein.

In some instances, the device may be placed in or on a subject. Forexample, a device may be ingested by a subject (see e.g. U.S. PatentPublication No. 2006/0182738, U.S. Patent Publication No. 2006/0062852,U.S. Patent Publication No. 2005/0147559, U.S. Patent Publication No.2010/0081894, which are hereby incorporated by reference in theirentirety). The device may be a pill or have another format that may passthrough the digestive tract of a subject. The device may be implantedwithin the subject. For example, the device may be subcutaneouslyimplanted within the subject. In another example, the device may be wornby the subject. The device may be attached to the subject via strap,adhesive, integrated into clothing, or any other technique. The devicemay comprise one or more needle or microneedle that may penetrate theskin of the subject. The device may be a patch that may be worn by thepatient. The device may include an automated lancing cartridge. Thecartridge may be disposable. One or more disposable component may beused to collect a sample from a subject. The disposable component mayprovide the sample to a non-disposable device. Alternatively, thedisposable component may be the sample processing device.

The device may receive a sample from the subject at one time.Alternatively, the device may periodically receive a sample from thesubject. This may be at regularly scheduled intervals or in response toone or more detected conditions. The device may optionally administertherapy to the subject. The device may administer one or moretherapeutic agent to the subject. The therapeutic agent may beadministered at scheduled intervals or in response to one or moredetected conditions. The therapeutic agent may be administered inresponse to one or more detected conditions from the sample.

In some instances, the device may be provided to a subject at adesignated sample collection site. Alternatively, the subject may obtainor come into contact with the device at any other location.

Examples of samples may include various fluid or solid samples. In someinstances, the sample can be a bodily fluid sample from the subject. Thesample can be an aqueous or gaseous sample. In some instances, solid orsemi-solid samples can be provided. The sample can include tissuesand/or cells collected from the subject. The sample can be a biologicalsample. Examples of biological samples can include but are not limitedto, blood, serum, plasma, nasal swab or nasopharyngeal wash, saliva,urine, gastric fluid, spinal fluid, tears, stool, mucus, sweat, earwax,oil, glandular secretion, cerebral spinal fluid, tissue, semen, vaginalfluid, interstitial fluids derived from tumorous tissue, ocular fluids,spinal fluid, throat swab, breath, hair, finger nails, skin, biopsy,placental fluid, amniotic fluid, cord blood, emphatic fluids, cavityfluids, sputum, pus, micropiota, meconium, breast milk and/or otherexcretions. The samples may include nasopharyngeal wash. Examples oftissue samples of the subject may include but are not limited to,connective tissue, muscle tissue, nervous tissue, epithelial tissue,cartilage, cancerous sample, or bone. The sample may be provided from ahuman or animal. The sample may be provided from a mammal, vertebrate,such as murines, simians, humans, farm animals, sport animals, or pets.The sample may be collected from a living or dead subject. The samplemay be collected fresh from a subject or may have undergone some form ofpre-processing, storage, or transport.

One or more, two or more, three or more, four or more, five or more, sixor more, seven or more, eight or more, ten or more, twelve or more,fifteen or more, or twenty or more different types of samples may becollected from a subject. A single type of sample or a plurality oftypes of samples may be collected from the subject simultaneously or atdifferent times. A single type of sample or a plurality of types ofsamples may be received or capable of being received by the devicesimultaneously or at different times. A plurality of types of samplesmay be processed by the device in parallel and/or in sequence. Forexample, a device may be capable of receiving both a bodily fluid and atissue, or a stool sample and a bodily fluid. In another example, adevice may be capable of receiving a plurality of types of bodilyfluids, such as blood and urine. For example, the device may be capableof receiving one or more type, two or more type, three or more types,four or more types, five or more types, six or more types, seven or moretypes, eight or more types, ten or more types, or twenty or more typesof bodily fluid.

Different collection mechanisms or the same collection mechanism of adevice may be used to collect a plurality of types of samples.

A subject may provide a sample, and/or the sample may be collected froma subject. A subject may be a human or animal. The subject may be amammal, vertebrate, such as murines, simians, humans, farm animals,sport animals, or pets. The subject may be living or dead. The subjectmay be a patient, clinical subject, or pre-clinical subject. A subjectmay be undergoing diagnosis, treatment, monitoring, and/or diseaseprevention. The subject may or may not be under the care of a healthcare professional. The subject may be a person of any age, an infant, atoddler, an adult or an elderly.

Any volume of sample may be provided from the subject. Examples ofvolumes may include, but are not limited to, about 10 mL or less, 5 mLor less, 3 mL or less, 1 microliter (μL, also “uL” herein) or less, 500μL or less, 300 μL or less, 250 μl, or less, 200 μL or less, 170 μL orless, 150 μL or less, 125 μL or less, 100 μL or less, 75 μl, or less, 50μL or less, 25 μL or less, 20 μL or less, 15 μL or less, 10 μL or less,5 μL or less, 3 μL, or less, 1 μL, or less, 500 nL or less, 250 nL orless, 100 nL or less, 50 nL or less, 20 nL or less, 10 nL or less, 5 nLor less, 1 nL or less, 500 pL or less, 100 pL or less, 50 pL or less, or1 pL or less. The amount of sample may be about a drop of a sample. Theamount of sample may be the amount collected from a pricked finger orfingerstick. The amount of sample may be the amount collected from amicroneedle or a venous draw. Any volume, including those describedherein, may be provided to the device.

A health care professional may include a person or entity that isassociated with the health care system. A health care professional maybe a medical health care provider. A health care professional may be adoctor. A health care professional may be an individual or aninstitution that provides preventive, curative, promotional orrehabilitative health care services in a systematic way to individuals,families and/or communities. Examples of health care professionals mayinclude physicians (including general practitioners and specialists),dentists, audiologists, speech pathologists, physician assistants,nurses, midwives, pharmaconomists/pharmacists, dietitians, therapists,psychologists, chiropractors, clinical officers, physical therapists,phlebotomists, occupational therapists, optometrists, emergency medicaltechnicians, paramedics, medical laboratory technicians, medicalprosthetic technicians, radiographers, social workers, and a widevariety of other human resources trained to provide some type of healthcare service. A health care professional may or may not be certified towrite prescriptions. A health care professional may work in or beaffiliated with hospitals, health care centers and other servicedelivery points, or also in academic training, research andadministration. Some health care professionals may provide care andtreatment services for patients in private homes. Community healthworkers may work outside of formal health care institutions. Managers ofhealth care services, medical records and health information techniciansand other support workers may also be health care professionals oraffiliated with a health care provider.

In some embodiments, the health care professional may already befamiliar with the subject or have communicated with the subject. Thesubject may be a patient of the health care professional. In someinstances, the health care professional may have prescribed the subjectto undergo a clinical test. The health care professional may haveinstructed or suggested to the subject to undergo a clinical testconducted at the sample collection site or by the laboratory. In oneexample, the health care professional may be the subject's primary carephysician. The health care professional may be any type of physician forthe subject (including general practitioners, and specialists).

A health care professional may receive a report from an authorizedanalytical facility. The health care professional that receives a reportmay be an ordering health care professional or health care professionalin the analytical facility and/or sample collection site.

A laboratory 110 may be in communication with a sample collection site120 and a health care professional 100. The laboratory may be incommunication with any number of sample collection sites and health careprofessionals. For example, the laboratory may be in communication withone or more, two or more, three or more, five or more, ten or more,fifteen or more, twenty or more, 30 or more, 50 or more, 100 or more,200 or more, 500 or more, 1000 or more, 5000 or more, 10,000 or more,100,000 or more, or 1,000,000 or more sample collection sites and/orhealth care professionals. In some systems, one, two, three, four, ormore laboratories may be provided that may communicate with any numberof sample collection sites and/or health care professionals. Thelaboratories may or may not communicate with one another. The samplecollection sites, laboratories, and/or health care professionals may bescattered geographically at any location. In some embodiments, thesample collection sites and/or health care professionals incommunication with a laboratory may be in the same geographic region(e.g., town, city, state, region, country). Alternatively, the samplecollection sites and/or health care professionals in communication witha laboratory may be scattered anywhere globally.

The laboratory may communicate with the health care professional and thesample collection site in any manner known in the art. In someembodiments, the laboratory may communicate directly with a devicelocated at the sample collection site or in or on a subject. Suchcommunications may be via electronic signals, radiofrequency signals,optical signals, cellular signals, or any other type of signals that maybe transmitted via a wired or wireless connection. Any transmission ofdata or description of electronic data or transmission describedelsewhere herein may occur via electronic signals, radiofrequencysignals, optical signals, cellular signals, or any other type of signalsthat may be transmitted via a wired or wireless connection. For example,data may be transmitted electronically from a sample collection site toa laboratory and vice versa. Data may be transmitted from a device whichmay be at the sample collection site or in or on a subject to thelaboratory and vice versa. Similarly, data may be transmittedelectronically from a laboratory to a health care professional and viceversa. The communications may be over a network such as a local areanetwork (LAN), wide area network (WAN) such as the Internet, personalarea network, a telecommunications network such as a telephone network,cell phone network, mobile network, a wireless network, a data-providingnetwork, or any other type of network. The communications may utilizewireless technology, such as Bluetooth or RTM technology. Alternatively,various communication methods may be utilized, such as a dial-up wiredconnection with a modem, a direct link such as TI, ISDN, or cable line.In some embodiments, a wireless connection may be using exemplarywireless networks such as cellular, satellite, or pager networks, GPRS,or a local data transport system such as Ethernet or token ring over aLAN. In some embodiments, the device may communicate wirelessly usinginfrared communication components. A device 130, personal computer,server, laptop computer, tablet, mobile phone, cell phone, satellitephone, smartphone (e.g., iPhone, Android, Blackberry, Palm, Symbian,Windows), personal digital assistant, Bluetooth device, pager, land-linephone, or other network device may be used in order to providecommunications. Such devices may be communication-enabled devices.

The laboratory may communicate with a device at a sample collectionsite, or in or on a subject. The device from the sample collection sitemay communicate with any communication-enabled device of the laboratory.The device may provide data to a cloud computing infrastructure that maybe accessed by any communication-enabled device of the laboratory. Thedevice may transmit data to the laboratory.

The data provided by the device may include data relating to a samplefrom a subject. The data may be information necessary and/or sufficientfor a qualitative and/or quantitative evaluation of the sample. The datamay include information for oversight. The data may include informationfor analysis. The data may be an electronic representation of a sample.An electronic representation of a sample may include an electronicrepresentation of the entire sample and/or any portion thereof. The datamay be electronic data. In some instances, the data may be electronicbits representative of the sample or reaction or reagents. The data maybe digital and/or analog. The data may be representative of one or moremeasurable parameter relating to, based on, or of the sample.

The data may be representative of a sample and/or any portion thereof.In some embodiments, the data is representative of a preparation of thecollected biological sample. The data may be collected prior to, during,and/or after the preparation of the sample. The data may be collectedover time. The data may comprise information of one or more conditionsunder which a preparation of the collected biological sample occurs.Examples of such conditions may comprise one or more characteristicslisted from the group: amount of the biological sample, concentration ofthe biological sample, quality of the biological sample, temperature, orhumidity. Such conditions may include environmental conditions.Environmental conditions may refer to conditions of the sample, and/orthe surroundings of the sample. The environmental conditions may beprovided prior to, during, and/or after the sample is received by thedevice, prepared by the device, and/or data is transmitted by thedevice.

The data may include amounts, concentrations, proportions, purity, orother information of sample, reagents, diluents, wash, dyes or any othermaterial that may be involved in the preparation of a sample, reactions,and/or controls/calibrations on the device. Physical and/or chemicalproperties of a sample and/or other materials, and/or a chemicalreaction may be measured at one or more points in time, and may beaggregated as data. In some embodiments, the data may determine whethera sample, reagent, diluents, wash, dye, or any other material issuitable for use in the device for said sample preparation and/or topermit subsequent qualitative and/or quantitative evaluation. Forexample, the data may be indicative of any error conditions that mayindicate a sample and/or any of the other materials have gone bad, orare otherwise unsuitable. In some instances, data is collected duringany processes the device is performing.

In some embodiments, the data may be representative of a chemicalreaction which may be run by the device. The chemical reaction mayinclude a chemical reaction with the sample, or without the sample. Thechemical reaction may include one or more reagents that may react withthe sample. The chemical reaction may include a control or calibrationreaction. The data representative of the reaction may include one ormore measurement of the chemical reaction. The data may also include therate or speed of the chemical reaction, and/or the acceleration of thechemical reaction. The data may include how complete a chemical reactionis (e.g., whether the chemical reaction has started, whether thechemical reaction is taking place, whether the chemical reaction iscomplete, how far along the chemical reaction is—e.g., 10%, 50%, etc.).The data may comprise information about a control reaction and achemical reaction involving the biological sample. These reactions mayoccur simultaneously and/or sequentially. The data may pertain to one ormore chemical reactions that may or may not occur simultaneously. Thedata may pertain to one or more sample preparation step that may or maynot occur simultaneously. The data may also include physical processing,such as centrifugation, pulveration, or any other actions describedherein, which may be represented through bits of data. The data can beutilized for oversight functionally performed on-board, remotely by ahealth care professional, and/or an external device configured to rendersuch oversight.

In some examples, the data may be one or more image, and/or audio datarepresentative of the sample. An image may be a digital image or ananalog image. The audio data may be digital and/or analog. The data mayinclude a video representative of the sample. An image may include avideo image. The data may include electronic data representative of adigital image and/or audio data of the sample. In one example, the datamay include video imaging that may capture changes over time. Forexample, a video may be provided to provide evaluation on dynamicactions, such as lysing, agglutination, mixing, movement of cells orother molecules in a sample or matrix, or assays.

The data may be collected at one time, or at a plurality of times. Thedata may be collected at discrete points in time, or may be continuouslycollected over time. Data collected over time may be aggregated and/oranalyzed. In some instances, data may be aggregated and may be usefulfor longitudinal analysis over time to facilitate diagnosis, treatment,and/or disease prevention.

Data may be collected from a device over time. The aggregated data froma single device for a given sample may be useful to facilitate thequalitative and/or quantitative evaluation of the sample. For example,it may be useful to determine how a sample reacts and/or changes overtime in order to provide a diagnosis, treatment, and/or diseaseprevention.

In some embodiments, data may be displayed in a lab report, medicalrecord, or any other type of display. The display may show patienthealth, provider's level of care, disease regression, progression,and/or onset through longitudinal analysis of high integrity data thatis may be obtainable more frequently or obtained frequently through thedescribed infrastructure over time.

Data may be collected from multiple devices. The aggregated data frommultiple devices may be useful to facilitate the qualitative and/orquantitative evaluation of the sample. The aggregated data may includedata relating to samples collected from a single subject, received atthe multiple devices. Alternatively, the aggregated data may includedata relating to samples collected from other subjects, received at themultiple devices. The aggregated data may be collected and/or stored ina database. The database may be accessed to provide data to perform alongitudinal analysis that takes past collected data into account.Trends, and changes over time may be monitored. The multiple devices maybe standardized and/or may provide data that is of sufficient quality,precision, and/or accuracy in order to aggregate the data and perform alongitudinal analysis therefrom. Very little or no variation may beprovided between devices. The devices may also create standardizedenvironments in which the sample preparation may occur. The standardizedenvironments may also be provided during a chemical reaction. Thedevices may also provide standardized pre-analytic steps. The multipledevices may be distributed globally. This may provide a globalevaluation infrastructure, which may better permit the monitoring ofdisease progression and/or regression. By standardizing a device, datamay be longitudinally analyzed looking at velocity of markers in one ormore subject over time. The data may be analyzed and/or displayed in aform of lab report or electronic medical record or decision supportsystem for consumers, providers, and/or payers (e.g., health plans,employers, governmental payers, etc.). Such display may include displaysof data over time, which may include trending analysis or other analysisrelating to changes in values, rates of changes, or rates of rates ofchange.

The data may be of a quality suitable for a longitudinal analysis overtime. The suitable quality of data may be useful for lab reports and/orelectronic medical records that may incorporate data collected overtime. This may include data collected over long periods of time (e.g.,multiple visits, or based off multiple samples), or shorter periods oftime (within a single visit, or based on single received sample). Thedata may have a sufficient quality, precision, and/or accuracy forlongitudinal analysis. For example, the sample may be collected from asubject a plurality of times. The sample may be collected from thesubject at different times. The samples may be collected atpredetermined intervals or according to a predetermined schedule.Alternatively, samples may be collected from the subject when one ormore condition or event triggers the collection. Multiple collections ofsamples may permit the sample to be analyzed over a period of time,thereby permitting longitudinal analysis. In some embodiments, in orderto permit longitudinal analysis, the data may have a high degree ofprecision and/or accuracy. In one example, the data may have acoefficient of variation of 20% or less, 15% or less, 10% or less, 9% orless, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% orless, 2% or less, 1% or less, 0.5% or less, or 0.1% or less over time.In some instances, the multiple devices may provide data having acoefficient of variation of 20% or less, 15% or less, 10% or less, 9% orless, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% orless, 2% or less, 1% or less, 0.5% or less, or 0.1% or less over time.

The data over time may be analyzed longitudinally. This may include thechange in data over time, the rate of change of data over time, the rateof change of the rate of change of data over time, or any derivativethereof. For example, velocity and/or acceleration of data change may becollected and/or analyzed. The increase and/or decrease in the datavalues and/or the various rates of change may be beneficial indetermining a diagnosis, treatment, and/or disease prevention.

The device is capable of processing a sample collected from a subject toyield data for subsequent analysis. The device may be configured tofacilitate collection of the sample from the subject. The device may beconfigured to receive the sample from the subject. The device may beconfigured to prepare the sample for a clinical test to detect and/orquantitate an analyte of interest. The device may comprise one or morereagents useful for the clinical test. The preparation or the clinicaltest may include a chemical reaction with the reagents. The device mayinclude one or more detector that may be capable of detecting signalsgenerated from processing the sample. The device may transmit datarelating to the sample. The data relating to the sample may include theraw data from the detected signals, such signals relating to unreactedsample, a sample that has undergone a reaction, and/or deviceconfigurations. In some instances, the device may pre-process some ofthe raw data to get it into a desired format, and transmit thepre-processed data. In some instances, the device may perform one ormore analysis step, and transmit analyzed data. Alternatively, thedevice does not perform any pre-processing and/or analysis. Thepre-processing and/or analysis may occur at the laboratory. In someinstances, pre-processing and/or analysis may occur at both the deviceand the laboratory. The laboratory may also include a hospital who maybe leveraging its pathologists so data can be transmitted to centers ofexcellence for the analysis of different types of specific conditions.

In one scenario, a device may perform a sample preparation step withoutperforming any analysis or receiving any oversight. The data from thesample preparation step may be sent to the laboratory, which may performthe analysis, and which may be an authorized analytical facility thatincludes oversight. In another scenario, the device may perform one ormore sample preparation step and may perform analysis on board. Datafrom the analysis may be sent to an authorized analytical facility,which may provide oversight. Alternatively, oversight may occur on boardthe device.

In some embodiments, oversight may include a review of the data in rawform, pre-processed form, or after analysis. Oversight may occur of aqualitative and/or quantitative evaluation of the sample. Examples of aqualitative evaluation of the sample may include but are not limited toreview of an image, video, or audio file. Examples of a quantitativeevaluation of the sample may include a numerical value indicating apresence or concentration level of a signal, series of signals, or ananalyte. Oversight may include one or more, or two or more of theexamples provided elsewhere herein. Oversight may be provided by ahealth care professional of an authorized analytical facility. In someother instances, oversight may be provided by a software program orautomated review system. The software program and/or automated reviewsystem may or may not be under the review or care of a qualified person,such as a health care professional (such as a laboratory director).

The device may duplicate manual analytical procedures. In someinstances, the device may perform automatically various steps, such aspipetting, preparing filtrates, heating, and/or measuring colorintensity. The device may be used in conjunction with materials tomeasure one or more analytes. The device may measure the presence orconcentration of one or more analytes. The device may includereagent-containing components that may serve as reaction units. Examplesof device components and steps that may be taken by the device can bedescribed in greater detail elsewhere herein.

The laboratory may communicate with a health care professional. Thelaboratory may generate a report based on analyzed data. In someinstances, the laboratory may analyze raw data or pre-processed dataprovided from the device. Alternatively, the laboratory may receiveanalyzed data from the device. The laboratory may or may not performfurther analysis and/or oversight from analyzed data received from thedevice.

The laboratory and/or device may generate a report that may present theanalyzed data in a meaningful or desired manner. The report may have aformat that may enable a viewer of the report to rely on the report tomake a medical determination. The laboratory and/or device may transmitthe report to a health care professional (or laboratory director). Insome embodiments, a pathologist, other health care professional, orother qualified person may review the report prior to transmitting thereport to the health care professional. A reviewing health careprofessional may review the report or qualitative and/or quantitativeevaluation useful for generating the report prior to transmission to anordering health care professional. Review or oversight may occur of theanalyzed data and/or report at the laboratory. Alternatively, review oroversight may occur on-board the device. The health care professionalwho receives the report may or may not rely on the report for diagnosis,treatment and/or disease prevention of the subject.

The laboratory and/or device may also provide a report to the subject.The report provided to the subject may be the same as or different fromthe report provided to the health care professional. The report providedto the health care professional may have more detail or vice versa. Theformats between the reports provided to the subject and the health careprofessional may or may not vary. Alternatively, the laboratory and/ordevice does not provide a report to the subject. The subject may receiveinformation based on the report from the health care professional. Adevice or laboratory can directly provide a lab report automatically toa consumer upon a test being performed and/or analysis being done, orbeing sent to a physician for review and/or after the physician'sreview.

Any transmission of data and/or reports may incorporate the use of acloud computing infrastructure. The sending party may provide the datato or have the data on a cloud computing infrastructure. The receivingparty and/or parties (e.g., health care professional or patient) mayaccess the cloud computing infrastructure. The cloud computinginfrastructure may be provided on the sending party side and/or thereceiving party side. Alternatively, traditional fixed data storagetechniques may be employed.

FIG. 1B shows a retailer 170 having a processing device 172 incommunication with a laboratory 160. The laboratory or reader device maybe in communication with a health care professional 150. As previouslydescribed, any discussion herein of retailers or other examples ofsample collection sites may apply to any type of sample collection site,and vice versa. A retailer may be provided at a first location and ahealth care professional may be provided at a second location. The firstlocation and the second location may be different locations. In someembodiments, the first and second locations are not proximate to oneanother. A laboratory may be provided at a third location. The thirdlocation may be a different location from the first and/or secondlocation. For example, the first, second, and third locations need notbe proximate to one another. The first, second, and/or third locationsmay be located in different facilities. Alternatively, the first,second, and/or third could all be the same location (point of service).

A retailer may be an entity that sells a product or service. In someembodiments, the product or service may relate to health or medicalcare. For example, the retailer may sell medicine or health caresupplies and/or insurance. In some embodiments, a retailer may be apharmacy (e.g., retail pharmacy, clinical pharmacy, hospital pharmacy),drugstore, chain store, supermarket, or grocer. Examples of retailersmay include but are not limited to Walgreens, CVS Pharmacy, Duane Reade,Walmart, Target, Rite Aid, Kroger, Costco, Kaiser Permanente, or Sears.

A retailer may be provided at a retailer location. In some embodiments,the retailer may be at a different geographic location than a healthcare professional and/or laboratory location. Alternatively, the healthcare professional may be provided at the retailer location.

A retailer 170 may have a sample processing device 172 at the retailer'slocation. In some embodiments, the retailer may have one or more, two ormore, three or more, four or more, five or more, six or more, or ten ormore sample processing devices at the retailer's location. The sampleprocessing device may be a point of service device. The sampleprocessing devices may be capable of communication withcommunication-enabled devices. For example, the sample processingdevices at a retailer location may communicate with one another.Alternatively, sample processing devices may communicate with otherreader devices at different locations, such as other sample collectionsites, or in or on a subject. Sample processing devices may communicatewith other types of communication-enabled devices, such as a computer ata laboratory and/or biometric devices. Such communications may be wiredor wireless.

The sample processing device 172 may be configured to accept a sample.The sample processing device may be configured to collect the sampledirectly from a subject. The sample processing device may be configuredto perform one or more sample preparation step on the subject. Thesample processing device may be configured to run an assay. In someembodiments, the sample processing device may be configured to run oneor more assay. The sample processing device may be capable of performingmultiplexed assays on a single sample. Where desired, the device isconfigured to perform at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40,50, 100, 200, 500, 1000 or more assays. The plurality of assays may berun simultaneously or in parallel. One or more control assays and/orcalibrators (e.g., including a configuration with a control of acalibrator for the assay/tests) can also be incorporated into the deviceto be performed in parallel if desired. In some instances, assays may berun in sequence, or any combination of in sequence and in parallel,based on the sample. The reader device may be effecting one, two, ormore chemical reactions or other processing tests (e.g., pulverizing).The sample processing device may be configured to detect one or moresignal relating to the sample. The sample may be a sample of bodilyfluid, a biological sample, or any other example as provided elsewhereherein.

In some embodiments, the sample processing device 172 may comprise acartridge 174. The cartridge may be removable from the sample processingdevice. In some embodiments, a sample may be provided to the cartridgeof the sample processing device. Alternatively, the sample may beprovided to another portion of the sample processing device. Thecartridge and/or device may comprise a sample collection unit that maybe configured to accept a sample. The sample processing device isdescribed in further detail elsewhere herein. The cartridge and devicemay be integrated into a single device or may be separable devices. Adevice may include a pill or patch that may link to a mobile device orother network device for processing.

A subject 176 may be provided at the retailer 170. The subject mayprovide a sample of bodily fluid to the sample processing device 172and/or cartridge 174 of the device. A bodily fluid may be drawn from asubject and provided to a device in a variety of ways, including but notlimited to, fingerstick, lancing, injection, and/or pipetting. Thebodily fluid may be collected using venous, or non-venous methods. Thebodily fluid may be provided using a bodily fluid collector. A bodilyfluid collector may include a lancet, microneedle, porous membrane(e.g., for a pill), capillary, tube, pipette, syringe, venous draw, orany other collector described elsewhere herein. In one embodiment, alancet punctures the skin and withdraws a sample using, for example,gravity, capillary action, aspiration, or vacuum force. The lancet maybe part of the sample processing device, part of the cartridge of thedevice, part of a system, or a standalone component. Where needed, thelancet may be activated by a variety of mechanical, electrical,electromechanical, or any other known activation mechanism or anycombination of such methods. In one example, a subject's finger (orother portion of the subject's body) may be punctured to yield a bodilyfluid. The bodily fluid may be collected using a capillary tube,pipette, or any other mechanism known in the art. The capillary tube orpipette may be separate from the device and/or cartridge, or may be apart of a device and/or cartridge. A transfer device may require noadditional processing steps, and may be pre-coated with anti-coagulantsor other pre-treatments in a single step. In another embodiment where noactive mechanism is required, a subject can simply provide a bodilyfluid to the device and/or cartridge, as for example, could occur with asaliva sample, or touching a pierced body part to a surface directly.The collected fluid can be placed within the device. A bodily fluidcollector may be attached to the device, removably attachable to thedevice, or may be provided separately from the device.

A cartridge 174 may be inserted into the sample processing device 172 orotherwise interfaced with the sample processing device. The cartridgemay be removed from the sample processing device. In one example, asample may be provided to a sample collection unit of the cartridge. Thesample may be provided directly to the cartridge. The sample may or maynot be provided to the sample collection unit via a bodily fluidcollector. A bodily fluid collector may be attached to the cartridge,removably attachable to the cartridge, or may be provided separatelyfrom the cartridge. The bodily fluid collector may or may not beintegral to the sample collection unit. The cartridge may then beinserted into the sample processing device. Alternatively, the samplemay be provided directly to the sample processing device, which may ormay not utilize the cartridge. The cartridge may comprise one or morereagents, which may be used in the operation of the sample processingdevice. Alternatively, one or more reagents may already be providedonboard the sample processing device.

The cartridge may or may not be disposable. Cartridges may be speciallyconfigured for one or more types of clinical tests. For example, a firstcartridge may have a first configuration to enable a first set of tests,and a second cartridge may have a second configuration to enable asecond set of tests. Alternatively, universal cartridges that may beconfigured for the same selection of tests may be provided. In someinstances, universal cartridges may be dynamically programmed forcertain tests through remote or on-board protocols.

When a cartridge is inserted into the sample processing device, one ormore components of the cartridge may be brought into fluid communicationwith other components of the sample processing device. For example, if asample is collected at a cartridge, the sample may be transferred toother portions of the sample processing device. Similarly, if one ormore reagents are provided on a cartridge, the reagents may betransferred to other portions of the sample processing device, or othercomponents of the sample processing device may be brought to thereagents. One or more components of the cartridge may be transferred inan automated fashion to other portions of the sample processing device,and vice versa. In some embodiments, the reagents or components of acartridge may remain on-board the cartridge. In some embodiments, nofluidics are included that require tubing or maintenance (e.g., manualor automated maintenance).

The sample processing device may be configured to be placed in or on asubject. The sample processing device may receive a sample from thesubject through a housing of the device. For example, if the sampleprocessing device is ingestible or implanted within a subject, it mayinclude a housing or a biocompatible coating. The biocompatible coatingmay be permeable to the desired sample. The sample may penetrate thecoating or housing of the sample processing device, thereby beingreceived by the sample processing device. If the sample processingdevice is on the subject, the sample may be received through the housingand/or coating of the device. Alternatively, the sample may be receivedusing one or more needle or microneedle that may be provided on thedevice (which may or may not be provided on the cartridge portion of thedevice).

The sample processing device may be configured to facilitate samplecollection, prepare the sample for a clinical test, and/or may compriseone or more reagents useful for a clinical test. In some embodiments,the sample processing device may be configured to run one or more testfrom the sample. A chemical reaction or other processing step may beperformed, with or without the sample. In some embodiments, assays, suchas immunoassays or nucleic acid assays may be run. Examples of stepsand/or tests that may be prepared or run by the device may include, butare not limited to immunoassay, nucleic acid assay, receptor-basedassay, cytometric assay, colorimetric assay, enzymatic assay,electrophoretic assay, electrochemical assay, spectroscopic assay,chromatographic assay, microscopic assay, topographic assay,calorimetric assay, turbidmetric assay, agglutination assay,radioisotope assay, viscometric assay, coagulation assay, clotting timeassay, protein synthesis assay, histological assay, culture assay,osmolarity assay, and/or other types of assays, centrifugation,separation, filtration, dilution, enriching, purification,precipitation, pulverization, incubation, pipetting, transport, celllysis, or other sample preparation steps, or combinations thereof.Sample processing may include chemical reactions and/or physicalprocessing. Sample processing may include the assessment of histology,morphology, kinematics, dynamics, and/or state of a sample, which mayinclude such assessment for cells. The device may perform one or more,two or more, three or more, or four or more of these steps/tests.

The sample processing device may be configured to perform one, two ormore assays on a small sample of bodily fluid. One or more chemicalreaction may take place on a sample having a volume, as describedelsewhere herein. For example one or more chemical reaction may takeplace in a pill having less than femtoliter volumes. In an instance, thesample collection unit is configured to receive a volume of the bodilyfluid sample equivalent to a single drop or less of blood orinterstitial fluid. The sample collection unit may be able to collect avolume of bodily fluid sample without piercing a subject's skin. In oneexample, light may be shined to optically measure a sample. Inadditional examples, ultrasound, MRI, or a scan may be used to performanalysis non-invasively.

The device may be capable of performing all on-board steps in a shortamount of time. For example, from sample collection from a subject totransmitting data and/or to analysis may take about 3 hours or less, 2hours or less, 1 hour or less, 50 minutes or less, 45 minutes or less,40 minutes or less, 30 minutes or less, 20 minutes or less, 15 minutesor less, 10 minutes or less, 5 minutes or less, 4 minutes or less, 3minutes or less, 2 minutes or less, 1 minute or less, 50 seconds orless, 40 seconds or less, 30 seconds or less, 20 seconds or less, 10seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less,500 ms or less, 200 ms or less, or 100 ms or less. The amount of timefrom accepting a sample within the device to transmitting data and/or toanalysis from the device may take about 3 hours or less, 2 hours orless, 1 hour or less, 50 minutes or less, 45 minutes or less, 40 minutesor less, 30 minutes or less, 20 minutes or less, 15 minutes or less, 10minutes or less, 5 minutes or less, 4 minutes or less, 3 minutes orless, 2 minutes or less, 1 minute or less, 50 seconds or less, 40seconds or less, 30 seconds or less, 20 seconds or less, 10 seconds orless, 5 seconds or less, 3 seconds or less, 1 second or less, 500 ms orless, 200 ms or less, or 100 ms or less.

A laboratory, device, or other entity or software may perform analysison the data in real-time. Analysis may include qualitative and/orquantitative evaluation of a sample. A laboratory, device, or otherentity may analyze the data within 48 hours or less, 36 hours or less,24 hours or less, 12 hours or less, 8 hours or less, 6 hours or less, 4hours or less, 3 hours or less, 2 hours or less, 1 hour or less, 45minutes or less, 30 minutes or less, 20 minutes or less, 15 minutes orless, 10 minutes or less, 5 minutes or less, 3 minutes or less, 1 minuteor less, 30 seconds or less, 15 seconds or less, 10 seconds or less, 5seconds or less, or 1 second or less. The analysis may include thecomparison of the data with one or more threshold value. The analysismay or may not include review by a pathologist or other qualifiedperson. The time included for analysis may or may not include time togenerate a report based on the data. The time included for analysis mayor may not include the time it takes to transmit a report to a healthcare professional.

A device 172 may be provided to a sample collection site 170 by alaboratory 160. The device may be sold to the sample collection site,leased/rented by the sample collection site, or the sample collectionsite may be used as a location at which the laboratory may conductsample collection and/or other steps.

Similarly, one or more cartridge 174 may be provided to the samplecollection site 170 by the laboratory 160. Alternatively, the cartridgemay be provided by another source. The cartridge may be sold to thesample collection site, leased/rented by the sample collection site, ormay be utilized as part of the location where the laboratory may collectsamples and/or perform other steps. The cartridge may be from a same ordifferent source as the device.

A laboratory 160 may have a processor 162 and a communication unit 164.A laboratory may be provided within a facility. The processor andcommunication unit may be provided within the facility. The laboratorymay have one or a plurality of processors and one or a plurality ofcommunication units.

A processor 162 may be configured to generate a report for a health careprofessional 150. The processor may be on a server side with a softwareperforming the processing. The processor may generate the report basedon data received from the sample processing device 172 or may provideoversight or analysis. The processor may perform qualitative and/orquantitative evaluation of the sample. In some embodiments, theprocessor may compare data received from the sample processing devicewith a threshold value. The threshold value may be for one or moreanalyte. Said comparison may include a comparison of whether a datavalue is greater than, equal to, or less than a threshold value. Thecomparison may include whether the data value is qualitatively and/orquantitatively the same as the threshold value. The comparison mayinclude one or more forms of statistical or physiological analysis ofthe data in relation to one or more stored values. Examples may includebest-fit analysis, and/or analysis such as curve fitting, extrapolation,interpolation, regression analysis, least squares, mean calculations,multivariate, simulation analysis, or variation calculations. Theprocessor may analyze the data received from the sample processingdevice. The processor may be configured to perform one or more steps forstatistical analysis of the data.

In some embodiments, a threshold value may refer to a single value. Thethreshold value may be a numerical value or an alphanumeric value. Thethreshold value may be a string or any other form of data. The thresholdvalue may refer to a range of values and/or set of values. A thresholdvalue may refer to a single value or a plurality of values. A pluralityof values may fall within one or more continuous spectrum.Alternatively, the plurality of values may be discrete. Examples ofthreshold ranges may include 1-100 units, or 5-10 units, and examples ofthreshold sets may include values falling within a list selected from 1unit, 3 units, 5 units, 8 units, 13 units, 20 units, or 50 units. A unitmay refer to any dimension or measureable quantity. Such values areprovided by way of example only. In some instances, the processor maycompare one or more image, video, or audio file or other data. Theprocessor may make such comparisons against one or more reference image,video, or audio file or other data. An algorithm may be capable ofevaluating one or more feature of the files or other data. In someinstances, the processor may automatically sort the files for viewing bya health care professional.

The processor may be able to access one or more data storage unit 166 a,166 b which may contain stored information. The stored information mayinclude the threshold value for one or more analyte. The threshold valuemay be useful for determining the presence or concentration of the oneor more analyte. The threshold value may be useful for detectingsituations where an alert may be useful. The data storage unit mayinclude any other information relating to sample preparation or clinicaltests that may be run on a sample. The data storage unit may includerecords or other information that may be useful for generating a reportfor a health care professional. The data storage units may also becapable of storing computer readable media which may include code,logic, or instructions for the processor to perform one or more step.

In some embodiments, a data storage unit 166 a may be provided at thelaboratory 160. The processor may be able to access the local datastorage unit. In another embodiment, the data storage unit 166 b may beprovided remote to the laboratory. For example, the data storage unitmay be provided at a sample collection site 170 or with a health careprofessional 150. The data storage unit may be provided on the device.Alternatively, the data storage unit may be provided at any otherlocation. Any combination of data storage unit locations may be utilizedby the processor. For example, the processor may access data storageunits that may be provided at the laboratory and external to thelaboratory.

In some embodiments, the data storage units may be electronic medicalrecords (EMR) or EMR databases. The data storage units may containinformation associated with a subject. The information associated withthe subject may include medical records of the subject, health historyof the subject, identifying information associated with the subject,payment information associated with the subject, or any otherinformation associated with the subject. The data storage units may bepayer databases. The data storage units may include informationassociated with a payer, such as a health insurance company orgovernmental payer. Such information may include treatment records,insurance records, or financial information associated with the subject.

One or more communication unit 164 may be provided at the laboratory160. The laboratory may be at the same location as or different locationfrom, or may actually be the same as the sample collection or processingcenter or provider or hospital office/location. Any description hereinof the laboratory may apply to any other locations provided herein andvice versa. The communication unit may be configured to receive datafrom a device 172. The communication unit may receive data relating to asample of a subject from the device at a sample collection site 170. Thecommunication unit may receive information about the subject from thedevice and/or the sample collection site. The communication unit mayreceive identifying information about the subject. The communicationunit may receive information from the device and/or any other machine(e.g., biometric devices, mobile devices) or entity associated with thesample collection site.

The communication unit 164 may be configured to transmit data to adevice 172 and/or any other machine or entity associated with the samplecollection site 170. In some embodiments, the communication unit mayprovide one or more protocol to the device. The communication mayprovide the protocol in addition to receiving data. The protocol mayeffect the collection of a sample, prepare the sample for a clinicaltest, or permit a chemical reaction with one or more reagents on thedevice. The protocol may effect the running of the clinical test on thedevice. The protocol may effect the detection of the presence and/orconcentration of an analyte at the device. Any description of detectionand/or analysis relating to the presence and/or concentration of ananalyte may include and/or be applied to assessing a disease condition.The protocol may effect the pre-processing of raw data and/or analysisof data at the device.

The communication unit may permit two-way communication unit between thesample collection site and the laboratory. The communication unit maypermit two-way communication between a sample processing device at asample collection site or in or on a subject, and a processor at thelaboratory. In some embodiments, one or more protocol may be sent to adevice based on data sent by the device. The data sent by the device mayinclude subject identifying information, information based on signalsgenerated and/or detected relating to the sample or reactions, deviceidentification information, cartridge identification information, or anyother information sent from the device. Data may be collected from thedevice depending on protocols provided to the device. The protocols maygovern the type of data that is collected and the actions performed bythe device. In some embodiments, one, two, or more subsequent sets ofprotocols may be sent to a device based on data collected from thedevice. The data from the device may provide feedback which may governfurther actions to be taken by the device, dictated by the protocols.

In alternate embodiments of the invention, the laboratory need not sendprotocols to the device. The protocols may be stored locally on thedevice. Alternatively, the system may provide protocols to the device.The protocols may be provided from an entity external to the device. Theprotocols may be on a cartridge.

The laboratory may have an output unit which may display or transmit thereport to the health care professional. The output unit may be a videodisplay. Alternatively, the output unit may be a communication unit. Inone example, the output unit may be a touchscreen. The touchscreen mayhave an intrinsic imaging capability through built-in sensors, which mayinclude LEDs or other light sources.

The device may have one or more identifier. The device may be capable oftransmitting the device identifier to the laboratory. One or morecomponents of the device may have an identifier. For example, acartridge may have one or more identifier. The cartridge identifier maybe readable by the device. For example, when a cartridge is provided tothe device, the device may automatically read the cartridge identifier.The device may transmit the cartridge identifier or other componentidentifiers to the laboratory. The device, cartridge, or other componentidentifiers may provide information about the configuration and/orcapabilities of the device, cartridge, or other components respectively.For example, an identifier may indicate which reagents or devicecomponents are available. A protocol may be transmitted to the devicefrom the laboratory based on the identification information received orfrom a device to a laboratory for review. A protocol may be run on thedevice based on the identification information.

An identifier may be a physical object formed on the device, cartridge,or other component. For example, the identifier may be read by anoptical scanner. In some embodiments, a camera may capture an image ofthe identifier and the image may be analyzed to identify the device,cartridge, or other component. In one example, the identifier may be abarcode. A barcode may be a 1D or 2D barcode. In some embodiments, theidentifier may emit one or more signal that may identify the device,cartridge, or component. For example, the identifier may provide aninfrared, ultrasonic, optical, audio, electrical, or other signal thatmay indicate the identity of the device, cartridge, or component. Theidentifier may utilize a radiofrequency identification (RFID) tag. Theidentifier may be stored on a memory of the device, cartridge, or othercomponent. In one example, the identifier may be a computer readablemedium.

The communication unit 164 may be configured to transmit data to ahealth care professional 150. In some embodiments, the communicationunit may transmit a report or analysis generated based on data relatingto the sample. The communication unit may be in communication with anetwork device used by the health care professional. For example, thecommunication unit may be capable of communicating with a computer,tablet, or mobile device of the health care professional.

Alternatively, another entity or source may generate a report, and/ortransmit a report to the health care professional. For example, alaboratory may analyze data provided by the device at a samplecollection site or in or on a subject or by a laboratory, hospital,sample collection center, or any other location described herein. Thelaboratory, device or another entity may generate a report or analysisbased on the analyzed data. The report may include longitudinal dataover time, which may include concentration or presence of one or moreanalytes or changes in disease states over time. The report and/oranalysis may make use of clinical outcome assessments, such as thosedescribed in U.S. Patent Publication No. 2009/0318775, which is herebyincorporated by reference in its entirety. The laboratory, device, theother entity, or an additional entity may transmit the report to thehealth care professional. Various rounds of analysis or data processingmay occur by one or more entity. The various entities may be provided atdifferent facilities. Alternatively, some of the various entities may beprovided at the same facility.

In some embodiments, the processor, communication unit, and data storageunit may be provided on the same machine. Alternatively, two or more ofthe processor, communication unit, and data storage unit may be providedon the same machine. The machine may be a computer, or any other networkdevice as described elsewhere herein. Two or more of the processor,communication unit, and data storage may be located on alaboratory-located computer. Alternatively, the processor, communicationunit, and data storage may all be located on different machines. In someinstances, multiple processors, communication units, and data storageunits may be provided that may be distributed over one or a plurality ofmachines.

FIG. 2 shows a sample processing device 200 in communication over anetwork 202 with one or more other devices 204 a, 204 b.

A sample processing device may be described further elsewhere herein.The sample processing device may be configured to accept one or morecartridge. The sample processing device may be configured to accept asample from a subject. The sample processing device may be configured tofacilitate collection of the sample, prepare the sample for a clinicaltest, and/or effect a chemical reaction with one or more reagents orother chemical or physical processing. The sample processing device maybe configured to detect one or more signals relating to the sample. Thesample processing device may be configured to run a test. The test mayinclude running one or more chemical reactions. The sample processingdevice may be configured to identify one or more properties of thesample. In some embodiments, the device may not be configured to performa qualitative and/or quantitative evaluation of the sample on board thedevice. Alternatively, the device may perform such a qualitative and/orquantitative evaluation. For instance, the sample processing device maybe configured to detect the presence or concentration of one analyte ora plurality of analytes or a disease condition in the sample (e.g., inor through a bodily fluid, secretion, tissue, or other sample).Alternatively, the sample processing device may be configured to detectsignals that may be analyzed to detect the presence or concentration ofone or more analytes (which may be indicative of a disease condition) ora disease condition in the sample. The signals may be analyzed on boardthe device, or at another location. Running a clinical test may or maynot include any analysis or comparison of data collected.

A sample processing device 200 may be configured to communicate over anetwork 202. The sample processing device may include a communicationmodule that may interface with the network. The sample processing devicemay be connected to the network via a wired connection or wirelessly.The network may be a local area network (LAN) or a wide area network(WAN) such as the Internet. In some embodiments, the network may be apersonal area network. The network may include the cloud. The sampleprocessing device may be connected to the network without requiring anintermediary device. Any other description of networks provided hereinmay be applied.

In some embodiments, the sample processing device 200 may communicateover the network 202 with another device 204 a, 204 b. The other devicemay be a communication-enabled device. For example, the other device maybe a client computer or a mobile device comprising a video display withat least one display page comprising data. The other device may be anytype of networked device, including but not limited to a personalcomputer, server computer, or laptop computer; personal digitalassistants (PDAs) such as a Palm-based device or Windows CE device;phones such as cellular phones, smartphones (e.g., iPhone, Android,Blackberry, etc.), or location-aware portable phones (such as GPS); aroaming device, such as a network-connected roaming device; a wirelessdevice such as a wireless email device or other device capable ofcommunicating wireless with a computer network; or any other type ofnetwork device that may communicate possibly over a network and handleelectronic transactions. Any discussion of any device mentioned may alsoapply to other devices, including those described elsewhere herein. Thesample processing device may communicate with one or more, two or more,three or more, or any number of other devices. Such communication may ormay not be simultaneous. Such communication may include providing datato a cloud computing infrastructure or any other type of data storageinfrastructure which may be accessed by other devices.

The other device 204 a, 204 b that may communicate with the sampleprocessing device 200 may have a video display. Video displays mayinclude components upon which information may be displayed in a mannerperceptible to a user, such as, for example, a computer monitor, cathoderay tube, liquid crystal display, light emitting diode display, touchpador touchscreen display, and/or other means known in the art for emittinga visually perceptible output. Video displays may be electronicallyconnected to a client computer according to hardware and software knownin the art.

In one implementation of the invention, a display page may include acomputer file residing in memory which may be transmitted from a serverover a network to a client computer or other device, which can store itin memory. A client computer may receive tangible computer readablemedia, which may contain instructions, logic, data, or code that may bestored in persistent or temporary memory of the client computer, or maysomehow affect or initiate action by a client computer. Similarly, oneor more devices may communicate with one or more client computers acrossa network, and may transmit computer files residing in memory. One ormore devices may communicate computer files or links that may provideaccess to other computer files.

At a client computer 204 a, mobile device 204 b, or any other networkdevice as described elsewhere herein, the display page may beinterpreted by software residing in memory of the client computer,mobile device, or network device, causing the computer file to bedisplayed on a video display in a manner perceivable by a user. Thedisplay pages described herein may be created using a software languageknown in the art such as, for example, the hypertext mark up language(“HTML”), the dynamic hypertext mark up language (“DHTML”), theextensible hypertext mark up language (“XHTML”), the extensible mark uplanguage (“XML”), or another software language that may be used tocreate a computer file displayable on a video or other display in amanner perceivable by a user. Any computer readable media with logic,code, data, instructions, may be used to implement any software or stepsor methodology. Where a network comprises the Internet, a display pagemay comprise a webpage of a type known in the art.

A display page according to the invention may include embedded functionscomprising software programs stored on a memory device, such as, forexample, VBScript routines, JScript routines, JavaScript routines, Javaapplets, ActiveX components, ASP.NET, AJAX, Flash applets, Silverlightapplets, or AIR routines.

A display page may comprise well known features of graphical userinterface technology, such as, for example, frames, windows, scrollbars, buttons, icons, and hyperlinks, and well known features such as a“point and click” interface or a touchscreen interface. Pointing to andclicking on a graphical user interface button, icon, menu option, orhyperlink also is known as “selecting” the button, option, or hyperlink.A display page according to the invention also may incorporatemultimedia features, multi-touch, pixel sense, IR LED based surfaces,vision-based interactions with or without cameras.

A user interface may be displayed on a video display and/or displaypage. The user interface may display a report generated based onanalyzed data relating to the sample. The report may include informationabout the presence or concentration of one or more analyte. The userinterface may display raw or analyzed data relating to the sample. Thedata may include information about the presence or concentration of oneor more analyte. The user interface may display an alert. One example ofan alert may be if an error is detected on the device, or if an analyteconcentration exceeds a predetermined threshold.

In some embodiments, one or more network devices 204 a, 204 b may beprovided at a laboratory facility. The network devices at the laboratorymay receive or access data provided by the sample processing device 200.In some other embodiments, one or more network devices may be providedat a health care professional location. In some embodiments, bothlaboratory devices and health care professional devices may be able toreceive or access data provided by the sample processing device. In anadditional example, the one or more network devices may belong to thesubject. One or more of the laboratory, health care professional, orsubject may have a network device able to receive or access dataprovided by the sample processing device. The one or more laboratoryhealth care professional and/or subject, or the network device of thelaboratory, health care professional, and/or subject may beauthenticated prior to being granted access to the data. For example,the laboratory personnel, health care professional, and/or subject mayhave a login ID and/or password in order to access the data. In someembodiments, the data can be sent to the email of the laboratorypersonnel, health care professional, and/or subject.

In some embodiments, the sample processing device may provide data to acloud computing infrastructure. The network device (e.g., of alaboratory, health care professional, or other entity) may access thecloud computing infrastructure. In some embodiments, on-demand provisionof computational resources (data, software) may occur via a computernetwork, rather than from a local computer. The network device maycontain very little software or data (perhaps a minimal operating systemand web browser only), serving as a basic display terminal connected tothe Internet. Since the cloud may be the underlying delivery mechanism,cloud-based applications and services may support any type of softwareapplication or service. Information provided by the sample processingdevice and/or accessed by the network devices may be distributed overvarious computational resources. Alternatively, they may be stored inone or more fixed data storage unit or database.

FIG. 3A illustrates a high level example of a sample processing device300. A sample processing device may be provided at any location,including a sample collection site. The sample processing device may bein or on a subject, or may be carried by the subject. The sampleprocessing device may be easily mobile or transportable. The sampleprocessing device may travel with the subject. The sample processingdevice may be a benchtop device or a handheld device. The sampleprocessing device may be located remote to a laboratory. Any number ofsample processing devices may be distributed geographically in anymanner. For example, one or more sample collection sites may have one ormore devices.

The sample processing device 300 may be configured to accept a removablecartridge 350. The removable cartridge and/or device may have any othercharacteristics or components as described elsewhere herein. Theremovable cartridge may be configured to accept a sample and/or deliverthe sample to the device. The removable cartridge may have one or morereagents provided thereon. For example FIG. 3B provides an illustrationof one or more reagents provided on the removable cartridge.Alternatively, one or more reagents 370 may be provided on board thedevice, such as shown in FIG. 3A. The device may comprise one or morereagent units that may contain and/or confine one or more reagents. Thereagents may originally be provided on the device, the reagents may beprovided to the reagent units from or on the cartridge, or both on-boardthe device and within the cartridge.

In other embodiments, the sample processing device need not have aremovable cartridge. One or more functions as described for thecartridge may be provided by the device itself.

The sample processing device and/or a cartridge may comprise allreagents, liquid- and solid-phase reagents, required to perform one ormore of the chemical reactions and/or other processing steps, includingphysical processing, as described elsewhere herein. For example, for aluminogenic ELISA assay the reagents within the device may include asample diluent, a detector conjugate (for example, three enzyme-labeledantibodies), a surface labeled with antibodies binders, a wash solution,and an enzyme substrate. Additional reagents can be provided as needed.In some embodiments, reagents can be incorporated into a device toprovide for sample pretreatment. Examples of pretreatment reagentsinclude, without limitation, white cell lysis reagents, reagents forliberating analytes from binding factors in the sample, enzymes, anddetergents. The pretreatment reagents can also be added to a diluentcontained within the device.

Reagents according to the present invention include without limitationwash buffers, enzyme substrates, dilution buffers, conjugates,enzyme-labeled conjugates, DNA amplifiers, sample diluents, washsolutions, sample pre-treatment reagents including additives such asdetergents, polymers, chelating agents, albumin-binding reagents, enzymeinhibitors, enzymes, anticoagulants, red-cell agglutinating agents,antibodies, or other materials necessary to run an assay on a device. Anenzyme-labeled conjugate can be either a polyclonal antibody ormonoclonal antibody labeled with an enzyme that can yield a detectablesignal upon reaction with an appropriate substrate. Non-limitingexamples of such enzymes are alkaline phosphatase and horseradishperoxidase. In some embodiments, the reagents comprise immunoassayreagents. Reagents defining assay specificity may be provided, which mayoptionally include, for example, monoclonal antibodies, polyclonalantibodies, proteins, nucleic acid probes or other polymers such asaffinity matrices, carbohydrates or lipids. In general, reagents,especially those that are relatively unstable when mixed with liquid,are confined separately in a defined region (for example, a reagentunit) within the device and/or cartridge.

In some embodiments, a reagent unit may contain a small volume ofreagent. For example, a reagent unit may contain approximately about 5microliters or less to about 1 milliliter of liquid. In someembodiments, the unit may contain about 20-200 microliters of liquid. Ina further embodiment, the reagent unit contains 100 microliters offluid. In an embodiment, a reagent unit contains about 40 microliters offluid. A reagent unit may include any volume described elsewhere herein,which may include volumes of sample. The volume of liquid in a reagentunit may vary depending on the type of assay being run or the sample ofbodily fluid provided. In an embodiment, the volumes of the reagents donot have to be predetermined, but must be more than a known minimum. Insome embodiments, the reagents are initially stored dry and dissolvedupon initiation of the assay being run on the device.

The sample processing device may comprise a display 310. The display maybe a video display or other type of user interface. The display mayfunction as a user interface. The display may permit a user to operatethe sample processing device. The display may be configured to accept aninput from the user relating to a subject identity, other informationabout the subject, information about the sample, information about oneor more clinical test, information about sample preparation steps,information about a laboratory, and/or information about a medical careprovider.

The display may output information to an operator of the device. Thedisplay may prompt the operator to perform one or more steps in theoperation of the device. The display may display information about thesample collected, the subject, and/or data relating to one or morepreparation step performed or chemical reaction run. The display mayoutput information about one or more automated process that may beimplemented by the device. The display may provide one or more alert foran error detected, or when one or more parameters are met (e.g., certaindetected signals exceed a predetermined threshold). A display maydisplay results on the device.

The sample processing device 300 may comprise one or more componentsuseful for collecting the sample, preparing the sample for a clinicaltest, and/or running a chemical reaction, or other test or analysis. Thesample processing device may also comprise one or more components usefulfor detecting one or more signal relating to the sample or components ofthe device. For example, the sample processing device may include, butis not limited to, a sample collection unit, centrifuge, magneticseparator, filter, pipette or other fluid handling system, vessels,containers, assay units, reagent units, heater, thermal block,cytometer, spectrophotometer, imaging systems, microscopy station, lightsource, optical detector, photometer, temperature sensor, motion sensor,or sensor for electrical properties. Fluid may be transferred from onecomponent to another via a fluid handling system, such as a pipette,channels, or pumps.

In some embodiments, the fluid handling system may be a pipettor. Thepipettor may be a multi-head pipettor. In some instances, each of thepipette heads may be of the same type or may be of different types. Forexample, the pipette heads may be air displacement pipettes and/orpositive displacement pipettes. In some instances, the fluid handlingsystem may be capable of picking up and/or removing one or more pipettetip. The pipette tips may be individually added or removed from thepipette head. The pipette head may transfer the pipette tip from a firstlocation to a second location. A pipette tip may be capable ofconnecting to and forming a fluid-tight seal with a pipette head orscrewing into it or attaching in other ways. A sample or other fluid maybe aspirated and/or dispensed by the pipette tip.

The pipette tip may have an interior surface and an exterior surface.The pipette tip may have a first end and an opposing second end. In someembodiments, both the first and second ends may be open. In someembodiments, the first end may have a diameter that is greater than thediameter of the second end. The pipette tip may or may not be coatedwith reagents and/or capturing binders such as antibodies. In someinstances, an interior surface of the pipette tip may be coated with areagent and/or capturing binders. A chemical reaction may take placewithin the pipette tip. The chemical reaction may take place within thepipette tip while the tip is attached to a pipette head, or when the tipis separated from the pipette head. Alternatively, chemical reactionsmay take place within one or more vessel. The pipette may deliver asample or other fluid to, or aspirate a sample or other fluid from, avessel. The pipette tip may be capable of being at least partiallyinserted into a vessel.

The pipettor may be utilized to transfer a sample or other fluid withinthe device. The pipettor may assist with the preparation of a sample.The pipettor may assist with the running of a chemical reaction.

The sample processing device may be capable of performing at least onesample preparation step and/or running one or more, two or more, threeor more, four or more, five or more, six or more, seven or more, eightor more, nine or more, ten or more, twenty or more, thirty or more, orfifty or more chemical reactions. The device may be capable ofperforming one or more, two or more, three or more, four or more, fiveor more, six or more, seven or more, eight or more, nine or more, ten ormore, twenty or more, thirty or more, or fifty or more different typesof assays. These may occur simultaneously and/or in sequence. The samplepreparation and/or chemical reactions that may occur may be governed byprotocols that may be individualized to a subject's needs and/or sentback and forth from a server and/or stored or inputted locally. Thesubject's needs may be based on a prescription or instructions that thesubject has received from a health care professional. The device may beconfigured to accommodate a wide range of sample preparation and/orchemical reactions.

The sample processing device 300 may include one or more detector 360which may be capable of detecting one or more signal relating to thesample. The detector may be able to detect all emissions from theelectromagnetic spectrum. Alternatively the detector may be able todetect a selected range of emission from the electromagnetic spectrum.For example, an optical detector may detect an optical signal relatingto a chemical reaction that had taken place on the device. An electricalproperty sensor or other sensor may detect the voltage, current,impedance, resistance, or any other electrical property of a sample. Atemperature sensor may determine the temperature of a thermal block,upon which a sample may rest. A sensor may determine the speed of acentrifuge. A sensor may determine the position, velocity, and/oracceleration of a pipette and/or the successful execution of a protocol.

One or more detectable signal may be detected by a detector 360. Thedetectable signal can be a luminescent signal, including but not limitedto photoluminescence, electroluminescence, chemiluminescence,fluorescence, phosphorescence or any emission from the electromagneticspectrum. In some embodiments, one or more label may be employed duringa chemical reaction. The label may permit the generation of a detectablesignal. Methods of detecting labels are well known to those of skill inthe art. Thus, for example, where the label is a radioactive label,means for detection may include a scintillation counter or photographicfilm as in autoradiography. Where the label is a fluorescent label, itmay be detected by exciting the fluorochrome with the appropriatewavelength of light and detecting the resulting fluorescence by, forexample, microscopy, visual inspection, via photographic film, by theuse of electronic detectors such as digital cameras, charge coupleddevices (CCDs) or photomultipliers and phototubes, or other detectiondevice. In some instances, cameras may utilize CCDs, CMOS, may belensless cameras (e.g., Frankencamera), open-source cameras, or mayutilize or any other visual detection technology known or laterdeveloped in the art. In some embodiments, imaging devices may employ2-d imaging, 3-d imaging, and/or 4-d imaging (incorporating changes overtime). Similarly, enzymatic labels are detected by providing appropriatesubstrates for the enzyme and detecting the resulting reaction product.Finally, simple colorimetric labels are often detected simply byobserving the color associated with the label. For example, conjugatedgold often appears pink, while various conjugated beads appear the colorof the bead.

In some embodiments, an imaging unit may be provided. Examples ofimaging units may include any of the detectors and/or optical detectiondevices as described elsewhere herein. For example, imaging units may becameras which may utilize CCDs, CMOS, may be lensless cameras (e.g.,Frankencamera), open-source cameras, or may utilize or any other visualdetection technology known or later developed in the art. An imagingunit may capture static images and/or may capture moving images. Forexample, the imaging unit may capture a series of digital images. Animaging unit may capture video images. An imaging device may be a cameraor a sensor that detects and/or records electromagnetic radiation andassociated spatial and/or temporal dimensions.

In one example, the imaging unit may capture one or more digital imageof a sample. For example, the imaging unit may capture an image of atissue sample. The picture of the tissue sample may be transmitted to apathologist or other health care professional. Analysis and/or oversightmay occur for the image of the tissue sample. Analysis and/or oversightmay occur on-board or remotely, by a health care professional or asoftware program. In other examples, the imaging unit may capture imagesof a sample, and/or any form of preparation of the sample such aschemical reactions or physical processing steps occurring with thesample. For example, a video may be taken of a chemical reaction. Anydescription herein of data may also apply to data representative ofimages, and vice versa.

The sample processing device 300 may have a processor 330 that mayprovide instructions to one or more components of the device. Theprocessor may act as a controller that may instruct one or morecomponent of the device. For example, the processor may provide aninstruction to a pipette to aspirate or dispense a fluid. The processormay provide an instruction that controls the temperature of a heater(which may optionally heat and/or cool the device). The processor mayprovide an instruction to an optical detector to detect one or moresignal. The processor may also receive instructions and/or collecteddata. For example, a processor may act in accordance with one or moreprotocol. The protocol may be provided on board the device or may beprovided from a source external to the device. The processor may alsoreceive data regarding signals detected by the device. The processor mayor may not analyze signals that have been detected by the device. Theprocessor may or may not compare one or more detected signal with athreshold value.

A communication module 340 may be provided on the device 300. Acommunication unit may be part of a laboratory or set-up which includesthe device. The communication module may permit the device tocommunicate with an external machine. For example, the communicationmodule may receive one or more protocol or set of instructions from anexternal source. In some embodiments, the external source may be alaboratory. The communication module may also permit the device totransmit data to an external machine. Data may be transmitted via atransmission unit. For example, the device may transmit data to alaboratory or to a health care professional. The device may transmitdata to a cloud computing infrastructure, which may be accessed by alaboratory, health care professional, or other entity. The communicationmodule may permit wireless and/or wired communication.

The sample processing device 300 may also comprise a power module 320.The power module may connect the device to an external power source, ormay be provided as an internal local power source. For example, thepower module may connect the device to a grid or utility. The device mayinclude a plug that may be connected to an electric socket. The devicemay be connected to any other external power source, which may includean electricity generation device, such as a generator, or any renewableenergy source (e.g., solar, wind, water, geothermal), or energy storagesource (e.g., battery, ultracapacitor). The power module may be a localpower source. For example, the power module may be an energy storagedevice, such as a battery or ultracapacitor. Any battery chemistry knownor later developed in the art may be used. Alternatively, a local powersource may include a local energy generation device, such as a devicethat utilizes renewable energy. The power module may provide electricityto run the rest of the sample processing device.

One or more component of the device may be contained within a housing.The housing may partially or completely surround components of thedevice. A display may be provided on the housing so that the display maybe visible.

The device may be a benchtop device. The device may be portable or worn.A plurality of devices may fit within a room. The device may have atotal volume of less than, greater than, or equal to about 4 m³, 3 m³,2.5 m³, 2 m³, 1.5 m³, 1 m³, 0.75 m³, 0.5 m³, 0.3 m³, 0.2 m³, 0.1 m³,0.08 m³, 0.05 m³, 0.03 m³, 0.01 m³, 0.005 m³, 0.001 m³, 500 cm³, 100cm³, 50 cm³, 10 cm³, 5 cm³, 1 cm³, 0.5 cm³, 0.1 cm³, 0.05 cm³, or 0.01cm³. The device may have a footprint covering a lateral area of thedevice. In some embodiments, the device footprint may be less than,greater than, or equal to about 4 m², 3 m², 2.5 m², 2 m², 1.5 m², 1 m²,0.75 m², 0.5 m², 0.3 m², 0.2 m², 0.1 m², 0.08 m², 0.05 m², 0.03 m², 100cm², 80 cm², 70 cm², 60 cm², 50 cm², 40 cm², 30 cm², 20 cm², 15 cm², 10cm², 7 cm², 5 cm², 1 cm², 0.5 cm², 0.1 cm², 0.05 cm², or 0.01 cm². Thedevice may have a lateral dimension (e.g., width, length, or diameter)or a height less than, greater than, or equal to about 4 m, 3 m, 2.5 m,2 m, 1.5 m, 1.2 m, 1 m, 80 cm, 70 cm, 60 cm, 50 cm, 40 cm, 30 cm, 25 cm,20 cm, 15 cm, 12 cm, 10 cm, 8 cm, 5 cm, 3 cm, 1 cm, 0.5 cm, 0.1 cm, 0.05cm, or 0.01 cm. The lateral dimensions and/or height may vary from oneanother. Alternatively, they may be the same. In some instances, thedevice may be a tall and thin device, or may be a short and squatdevice. The height to lateral dimension ratio may be greater than orequal to 100:1, 50:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7:1, 6:1, 5:1, 4:1,3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:20, 1:30,1:50, or 1:100.

The device may have any weight. The device may be capable of beinglifted manually by a human. The device may be capable of being on or ina human. The device may be molted or mounted to a ground, wall, ceiling,and/or wall. The device may be sized and/or shaped to be ingestible by ahuman. Examples of device weights may include but are not limited toless than, greater than, or equal to about 20 kg, 15 kg, 10 kg, 8 kg, 6kg, 5 kg, 4 kg, 3 kg, 2 kg, 1 kg, 0.7 kg, 0.5 kg, 0.3 kg, 0.1 kg, 0.05kg, 0.01 kg, 5 g, 1 g, 0.5 g, 0.1 g, 0.05 g, or 0.01 g.

In some embodiments, methods above, alone or in combination, areimplemented with the aid of one or more systems and devices provided inPatent Cooperation Treaty Application No. PCT/US11/53188, the content ofwhich is incorporated herein in its entirety.

FIG. 4 shows an example of a sample collection, processing, and analysismethod. One or more of the following steps may occur in such a method.The order of the steps may be modified, or one or more step may beoptional or may be substituted by another step.

The method may include collecting a sample from a subject 400, preparingthe sample for running a chemical reaction 410, permitting a chemicalreaction with one or more reagent 420, detecting a signal relating tothe sample, chemical reaction, and/or component of the device 430,pre-processing the detected signals without performing analysis,analyzing the data 450, generating a report based on the data 460,transmitting a report 470, providing the report to a health careprofessional 480, and/or displaying a report on the device and/or screenor other display device.

One or more of these steps may be provided by any device or entity. Thedemarcations illustrated in the figures are provided by way of exampleonly, and are in no way limiting. For example, a sample may be collected400 external to a device 490. Alternatively, the sample may be collecteddirectly at the device, or may be collected by the device. This mayoccur at a sample collection site. The sample prep 410, chemicalreaction 420, or signal detection steps 430, may be performed by thedevice 490.

In some embodiments, a sample may be prepared for a subsequentqualitative and/or quantitative evaluation. Such a sample preparationfor evaluation step may include one or more of the sample prep 410,chemical reaction 420, and/or signal detection 430 steps. In someembodiments, a sample may be processed by receiving the sample 400,and/or preparing the sample for a subsequent qualitative and/orquantitative evaluation, to yield data necessary for the subsequentqualitative and/or quantitative evaluation. Sample processing may alsoinclude transmitting the data from the device. In some instances, thedata may be transmitted to a health care professional of an authorizedanalytical facility.

One, two or all these of these steps may take place, and one, two, orall of the steps that take place may occur at the device at a samplecollection site. Alternatively, they may take place at another entity,such as a laboratory. The point of service site near or on the body(such as the home) of the subject may be a laboratory or samplecollection site.

Data collected by the device may be in a raw state. This may includesignals detected at the device. The data may optionally undergopre-processing 440. Data pre-processing does not perform actual dataanalysis or comparison with any threshold values. Data pre-processingmay involve modifying the format of data. In some instances, datapre-processing may occur at a device 490 at a sample collection site.Then the pre-processed data may be transmitted to a laboratory.Alternatively, data pre-processing 440 may occur at a laboratory 492.Raw data may be sent from a device to the laboratory wherepre-processing may occur. Alternatively, no pre-processing occurs withinthe method.

Data analysis may occur 450 in accordance with an embodiment of theinvention. Data analysis may include a subsequent qualitative and/orquantitative evaluation of a sample. The quantitative and/or qualitativeanalysis may involve a determination of clinical relevance of thebiological sample or lack thereof. Data analysis may include one or morecomparison of the data with a threshold value. Said comparison may beused to determine the presence or concentration of one or more analyte,or may be useful for analytical methods and/or pathological analysisdescribed elsewhere herein. Data analysis may occur at a laboratory 492.In some embodiments, the laboratory may be a certified laboratory. Thedata that may be analyzed may be raw data or pre-processed data. Adevice may process a sample without analyzing the sample. Data analysisdoes not occur on the device in this scenario. In some embodiments,processing the sample on the device does not yield a determination ofthe presence or concentration level of one or more analytes, two or moreanalytes, three or more analytes, four or more analytes, five or moreanalytes, six or more analytes, seven or more analytes, eight or moreanalytes, nine or more analytes, ten or more analytes, twelve or moreanalytes, fifteen or more analytes, or twenty or more analytes. In someinstances, processing the sample on the device does not yield adetermination of the presence or concentration of one or more, or anynumber of analytes (including those described elsewhere herein),belonging to the categories of cardiac marker, blood gas, electrolyte,lactate, hemoglobin, or coagulation factors. In some embodiments,processing the sample on the device does not yield a determination ofthe presence or concentration of one or more, two or more, three ormore, or any number of analytes (including those described elsewhereherein), belonging to the following: sodium, potassium, chloride, TCO₂,anion Gap, ionized calcium, glucose, urea nitrogen, creatinine, lactate,hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂, ACTKaolin, ACT Celite, PT/INR, cTnl, CK-MB, and BNP. In some instances,processing the sample does not include a display of the presence orconcentration of one or more, or any number of analytes (including thosedescribed elsewhere herein), belonging to the categories of cardiacmarker, blood gas, electrolyte, lactate, hemoglobin, or coagulationfactors. Similarly, in some instances, processing the sample does notinclude a display of the presence or concentration of one or more, orany number of analytes (including those described elsewhere herein),belonging to the following: sodium, potassium, chloride, TCO₂, anionGap, ionized calcium, glucose, urea nitrogen, creatinine, lactate,hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂, ACTKaolin, ACT Celite, PT/INR, cTnl, CK-MB, and BNP.

Data analysis may include a qualitative and/or quantitative evaluationof the sample. Said qualitative and/or quantitative evaluation of thesample may yield a determination of the presence or concentration of oneor more, two or more, three or more, four or more, five or more, six ormore, ten or more, fifteen or more, or twenty or more analytes. In someexamples, analytes may belong to categories involved in one or more ofthe following types of research and/or analyses: immunoassay, nucleicacid assay, receptor-based assay, cytometric assay, colorimetric assay,enzymatic assay, electrophoretic assay, electrochemical assay,spectroscopic assay, chromatographic assay, microscopic assay,topographic assay, calorimetric assay, turbidmetric assay, agglutinationassay, radioisotope assay, viscometric assay, coagulation assay,clotting time assay, protein synthesis assay, histological assay,culture assay, osmolarity assay, and/or other types of assays orcombinations thereof. Analytes being tested may be involved in one ormore types of reactions selected from the following: Chemistry—RoutineChemistry, Hematology (includes cell-based assays, coagulation andandrology), Microbiology—Bacteriology (includes “Molecular Biology”),Chemistry—Endocrinology, Microbiology—Virology, DiagnosticImmunology—General Immunology, Chemistry—Urinalysis,Immunohematology—ABO Group & Rh type, Diagnostic Immunology—SyphilisSerology, Chemistry—Toxicology, Immunohematology—Antibody Detection(transfusion), Immunohematology—Antibody Detection (non-transfusion),Histocompatibility, Microbiology—Mycobacteriology,Microbiology—Mycology, Microbiology—Parasitology,Immunohematology—Antibody Identification, Immunohematology—CompatibilityTesting, Pathology—Histopathology, Pathology—Oral Pathology,Pathology—Cytology, Radiobioassay, and/or Clinical Cytogenetics. One ormore measurement may include: proteins, nucleic acids (DNA, RNA, hybridsthereof, microRNA, RNAi, EGS, Antisense), metabolites, gasses, ions,particles (including crystals), small molecules and metabolites thereof,elements, toxins, enzymes, lipids, carbohydrates, prion, formed elements(e.g., cellular entities (e.g., whole cell, cell debris, cell surfacemarkers)). In some embodiments, one or more analytes belonging tocategories of cardiac marker, blood gas, electrolyte, lactate,hemoglobin, or coagulation factors. In some embodiments, one or moreanalytes may include sodium, potassium, chloride, TCO₂, anion Gap,ionized calcium, glucose, urea nitrogen, creatinine, lactate,hematocrit, hemoglobin, pH, PCO₂, PO₂, HCO₃, base excess, sO₂, ACTKaolin, ACT Celite, PT/INR, cTnl, CK-MB, and/or BNP.

The data that may be analyzed may be provided from a device 490 or maybe modified at the laboratory 492 or other entity prior to beinganalyzed. In another embodiment of the invention, the data analysis 450may occur on the device without occurring at a laboratory.Alternatively, data analysis may occur on both the device and at thelaboratory or the device may be the laboratory. The analysis may occurat a point of service location, such as a home, office, doctor'soffice/hospital, retailer site, or other point of service location. Anydescription herein of a laboratory location or other location, may applyto any other point of service location described elsewhere herein.

A report may be generated 460 based on the data. A report may be basedon analyzed data 450 or may be based on data in its raw or pre-processedform. The report may be generated based on a qualitative and/orquantitative evaluation of the sample. The report may be generated at alaboratory 492, such as an authorized analytical facility.Alternatively, the report can be generated at the device, or by anyother entity. The report may be transmitted 470. The report may betransmitted by the same entity that generated the report. Alternatively,a different entity can transmit the report. The report may betransmitted by a laboratory 492, such as an authorized analyticalfacility, a device 490, cartridge, or any other entity.

The report may be received by a health care professional 480. The healthcare professional may be provided at a location separate from the device490 and/or the laboratory 492. The health care professional may becapable of relying on the report in order to diagnose, treat, and/orprovide disease prevention for the subject.

Thus, as previously described, any one or more of these steps may beoptional. Any one or more of these steps may be performed at a samplecollection site or in or on a subject by a device 490 or may beperformed at a laboratory 492, or at any other entity. In someembodiments, the location where a data analysis 450 step may beperformed may be certified, or may undergo review or oversight.

A device may be configured to process a sample. Sample processing mayinclude receiving a sample 400 and/or preparing a sample for subsequentqualitative and/or quantitative evaluation, to yield necessary for thesubsequent qualitative and/or quantitative evaluation. Preparing thesample for subsequent qualitative and/or quantitative evaluation mayinclude one or more sample preparation step 410, chemical reaction stepor physical processing step 420, and/or detection step 430. Processingthe sample may include adding one or more reagent or fixatives. Sampleprocessing may optionally also include transmitting data electronically.The data may be transmitted to a health care professional of anauthorized analytical facility and/or displayed on the screen. The datamay be transmitted and/or displayed simultaneously.

The sample may be collected from a subject 400 in any manner describedelsewhere herein. For example, a fingerstick may collect the sample fromthe subject. In other examples, feces, urine, or tissue may be collectedin an operating and/or emergency room, or any other sample collectionmechanism described elsewhere herein may be utilized. The collectedsample may be provided to a device 490. The sample collection may occurat a sample collection site, or elsewhere. The sample may be provided tothe device at a sample collection site.

Optionally, the sample may be prepared for a chemical reaction and/orphysical processing step 410. The sample preparation step may includeone or more of the following: centrifugation, separation, filtration,dilution, enriching, purification, precipitation, incubation, pipetting,transport, chromatography, cell lysis, cytometry, pulverization,grinding, activation, ultrasonication, micro column processing,processing with magnetic beads or nanoparticles, or other samplepreparation steps. The sample may be transferred within a device. Samplepreparation may include one or more step to separate blood into serumand/or particulate fractions, or to separate any other sample intovarious components. Sample preparation may include one or more step todilute and/or concentrate blood, or other biological samples. Samplepreparation may include adding an anti-coagulant or other ingredients toa sample. Sample preparation may also include purification of a sample.Sample preparation may involve altering the density of a sample, and/orcreating a density profile of a sample. In some instances, denserportions of a sample may be separated from less dense portions of asample. Sample preparation may include separating solid components of asample from aqueous components of a sample. In some examples, samplepreparation may involve centrifugation, incubation and/or cell lysis.Sample preparation may include causing the sample to flow, such as alaminar flow. Sample preparation may include transporting a sample fromone portion of a device to another. Sample preparation may includeincubating a sample. The sample preparation may include a process torender a biological sample applicable prior to undergoing a chemicalreaction and/or running an assay. The sample preparation step may rendera biological sample ready for running one or more clinical test, whichmay include adding a series of reagents, running a protocol and/orrunning an assay.

Optionally, the sample may undergo a chemical reaction with a reagent420. The chemical reaction may occur following a sample preparationstep. Alternatively, the chemical reaction need not follow a samplepreparation step. Sample preparation steps may occur prior to,concurrently with, and/or after a chemical reaction. In someembodiments, preparing a sample for qualitative and/or quantitativeevaluation may include permitting a chemical reaction. One or more typeof assay, as described elsewhere herein may occur. For example, a samplepreparation step (or e.g., a chemical reaction that may occur whilepreparing a sample for qualitative and/or quantitative evaluation) mayinclude one or more of the types of chemical reactions selected fromimmunoassay, nucleic acid assay, receptor-based assay, cytometric assay,colorimetric assay, enzymatic assay, electrophoretic assay,electrochemical assay, spectroscopic assay, chromatographic assay,microscopic assay, topographic assay, calorimetric assay, turbidmetricassay, agglutination assay, radioisotope assay, viscometric assay,coagulation assay, clotting time assay, protein synthesis assay,histological assay, culture assay, osmolarity assay, and/or other typesof assays or combinations thereof. In some embodiments, a heater and/orthermal block may be employed. The chemical reaction may includeproviding the sample at a desired temperature. The chemical reaction mayalso include maintaining and/or varying the temperature of the samplebefore, during, and/or after the chemical reaction. Any descriptionherein of chemical reaction may include any type of reaction that mayoccur in the device. For instance, chemical reactions may includephysical interactions, chemical interactions, and/or other physicalinteractions or transformations. In some embodiments, a display (such asa screen) or sensors in a device may conduct imaging externally. Forexample, the device may be capable of conducting MRI, ultrasound, orother scans.

The sample preparation and/or chemical reaction may occur in response toone or more instructions. The instructions may be stored locally on thedevice or may be provided from an external source. In some embodiments,the external source is a laboratory. In some embodiments, the samplepreparation and/or chemical reaction procedures may be self-educated.For example, they may be capable of picking up different ways ofpreparing a sample and/or making it ready for analysis. In someembodiments, the sample preparation procedures may be able to selfadjust to utilize various sample preparation techniques given a set ofparameters. The sample preparation adjustment or maintenance may or maynot rely on signals detected relating to a sample, and/or to parametersand/or instructions provided by an operator. The sample preparationprocedures may be self-learning. One or more controller that may provideinstructions to conduct a sample preparation and/or chemical reactionmay be capable of self-learning.

The adjustments may be made in response to new instructions that may begenerated locally on the device or that may be provided from theexternal source. For example, new instructions may be updated and/orpushed down from the external source. There may be a dynamic process inwhich the sample preparation and/or chemical reaction and/or physicalprocessing steps are performed in accordance with changeableinstructions. Any description herein relating to a sample preparationand/or chemical reaction may also include any physical processing steps.

One or more signal may be detected 430 from the device. The signal maybe detected after a sample preparation step has been done and/or after achemical reaction and/or physical processing step has taken place. Insome embodiments, one or more signal may be detected even if no samplepreparation and/or chemical reaction has taken place on the sample. Thesignals may be based on a reading of a sample that may or may not haveundergone an assay. The signals may be based on a measurement relatingto the device.

In some instances, one or more additional sample preparation steps mayoccur. For instance, an additional sample preparation for qualitativeand/or quantitative evaluation may occur. Such preparation may be madebased on at least one of: prior preparation of the biological sampleand/or analysis of the data by the health care professional. Reflextesting may occur based on earlier results. The reflex testing may occurin an automatic and dynamic manner before, during, or after thetest/analyses. Earlier evaluation may yield further testing, which maybe automated.

Optionally, data may undergo pre-processing 440. Raw data of detectedsignals may or may not undergo pre-processing. Pre-processing may affectthe format of the raw data. For example, the pre-processing maynormalize a format of the data. The pre-processing may put the data intoa desired form. Pre-processing may occur without performing any analysisof the data. In some embodiments, the pre-processing may alter the formof the data without altering the content of the data. In some instances,pre-processing does not compare the data with any threshold values orperform any valuation judgments.

The data may be analyzed 450, as described elsewhere herein. Dataanalysis may include a subsequent qualitative and/or quantitativeevaluation of a sample. Optionally, a report may be generated based onthe raw data, pre-processed data, or the analyzed data. The reportand/or the data may be transmitted to a health care professional. Asoftware system may perform chemical analysis and/or pathologicalanalysis, or these could be distributed amongst combinations of lab,clinical, and referenced/contracted specialty personnel (e.g., lab andJohn's Hopkins laboratory for specialty experts of some diseases or toengage them as part of/in a certified laboratory).

In some embodiments, the report may be reviewed before being transmittedto the health care professional. In some instances, the data may bereviewed before or after the report is generated. The review may occurby one or more pathologist or other qualified person. The pathologistmay be associated with a laboratory 492. The pathologist may or may notbe physically located at the laboratory facility. The pathologist may beemployed by the laboratory. For an authorized analytical facility,oversight may be provided via a regulatory body. In some embodiments,the laboratory may be a CLIA certified laboratory. A board certifiedentity (which may include board-certified personnel) may review thedata/reports and provide a measure of quality control and verification.In some embodiments, the board certified entity may include one or morepathologist.

In some embodiments, a device may be a certified device. The device maybe under the oversight of a regulatory body. A board certified entitymay review the data/reports of the device and provide a measure ofquality control, performance of calibrators, of a test, andverification. A health care professional may review and/or provideoversight of the data/reports from the device. Alternatively, a softwareprogram may be provided that may review data generated by the device.The software program may be created by or under the review of a healthcare professional. The software program may be maintained by anauthorized person, such as a health care professional.

FIG. 8 shows examples of a system providing sample processing, analysis,and oversight.

FIG. 8( i) shows an example of a device 800 which may be capable ofperforming a sample processing 802 step. The device may be capable ofcommunicating with a laboratory 810. The laboratory may be capable ofperforming a subsequent analysis 812 step and may provide oversight 814.Oversight and/or analysis may be provided by a health care professionaland/or software program. The device may communicate with the laboratoryacross a network 850, including any of those described elsewhere herein.A cloud computing infrastructure may be provided. The device may beprovided in or on a subject, or at a sample collection site. Thelaboratory may be an authorized analytical facility, such as a CLIAcertified facility which could be the device or cartridge.

FIG. 8( ii) shows an example of a device 820 which may be capable ofperforming a sample processing 822 step and an analysis step 824. Thedevice may be capable of communicating with a laboratory 830. Thelaboratory may be capable of providing oversight 832. Oversight may beprovided by a health care professional and/or a software program. Thedevice may communicate with the laboratory across a network 860,including any of those described elsewhere herein. A cloud computinginfrastructure may be provided. The cloud computing infrastructure maybe part of the system/infrastructure/device. The device may be providedin or on a subject, or at a sample collection site. The laboratory maybe an authorized analytical facility, such as a CLIA certified facility.

FIG. 8( iii) shows an example of a device 840 which may be capable ofperforming a sample processing 842 step, analysis step 844, andproviding oversight 846. In some embodiments, the oversight may beprovided by an oversight software program on the device. The device maycommunicate with a network 870, including any of those describedelsewhere herein. A cloud computing infrastructure may be provided. Thedevice may be provided in or on a subject, or at a sample collectionsite. In some embodiments, the device may be certified by a regulatorybody. In some instances, the device may be CLIA certified.

In some embodiments, a method for evaluating a biological sample may beprovided. The method may include receiving and/or preparing a sample onboard a device. The method may include performing analysis on-board thedevice. Alternatively, the method may include performing analysisexternal and/or remote to the device. For example, the analysis mayoccur at a laboratory or by an affiliate of the laboratory. In someembodiments, the analysis may occur both on-board the device andexternal to the device.

The analysis may be performed by a health care professional of alaboratory, or any other affiliate of the laboratory. The analysis maybe performed by a software program. A processor may perform one or moresteps of the software program, thereby effecting such analysis. In someembodiments, one, two or more types of analysis may be provided by theanalysis software program. In some embodiments, the analysis may beperformed by both the health care professional and the software program.In some examples, the analysis may be performed by a software programon-board the device, by a health care professional external to thedevice, and/or by a software program external to the device.

The method may further include providing oversight of the analysis. Themethod may include performing oversight on-board the device.Alternatively, the method may include performing oversight externaland/or remote to the device. For example, the oversight may occur at alaboratory or by an affiliate of the laboratory. In some embodiments,the oversight may occur both on-board the device and external to thedevice.

In some embodiments, analysis may be conducted by a health careprofessional and oversight may be conducted by a health careprofessional, analysis may be conducted by a health care professionaland oversight may be conducted by a software program, analysis may beconducted by a software program and oversight may be conducted by ahealth care professional, or analysis may be conducted by a softwareprogram and oversight may be conducted by a software program. The samehealth care professional or different health care professionals may beused for analysis and/or oversight. The same software program ordifferent software programs may be used for analysis and/or oversight.Any description of laboratories, health care professionals, software,and/or infrastructure that may perform oversight may also apply toanalysis, or vice versa.

The oversight may be performed by a health care professional of alaboratory, or any other affiliate of the laboratory. The oversight maybe performed by a software program. A processor may perform one or moresteps of the software program, thereby effecting such oversight. In someembodiments, the oversight may be performed by both the health careprofessional and the software program. In some examples, the oversightmay be performed by a software program on-board the device, by a healthcare professional external to the device, and/or by a software programexternal to the device. Any combination of analysis and oversight may beprovided.

FIG. 5 shows a laboratory benefit management (LBM) entity 510 incommunication with a payer 500 and sample collection site 520. The LBMmay be in communication with a payer at a payer location and the samplecollection site at a point of service location. The LBM may be providedat a facility at the LBM location. The LBM may be at a differentlocation than the payer and the sample collection site. In someembodiments, the sample collection site may be a retailer, insurancecompany, entity, or any sample collection site as described elsewhereherein. For example, the payer, LBM, and point of service may beprovided in different facilities.

The LBM 510 may be an entity. For example, the LBM may be a company,corporation, organization, partnership, business, or one or moreindividuals that form an entity. The LBM may be configured tocommunicate with one or more other entity regarding financialtransactions and services. The LBM may provide instructions regardingfinancial transactions and services and manage financial processes.

The payer 500 may be an entity that may pay or partially pay for one ormore health or medical related services for a subject. The payer mayhave a contract or agreement with the subject or a sponsor of thesubject to provide some form of medical coverage. The payer may be apublic payer or private payer. In some instances, the payer may be agovernment payer or a health insurance company. Examples of governmentpayers may include, but are not limited to Medicare, Medicaid, FederalEmployees Health Benefits Program, Veterans Health Administration, StateChildren's Health Insurance Program, Military Health System/TRICARE,Indian Health Service, or other publicly funded health insuranceprograms. Examples of types of private payers may include, but are notlimited to, health maintenance organizations (HMO), preferred providerorganization (PPO), independent practice association (IPA), point ofservice (POS) plans, or managed care or indemnity insurance plans.Examples of health insurance companies may include but are not limitedto Aetna, Blue Cross Blue Shield Association, CIGNA, Kaiser Permanente,Humana, Health Net, UnitedHealth Group, or Wellpoint.

The sample collection site 520 may be a point of service location. Asample collection site may be provided at a point of service location.Any discussion of a point of service may also apply to a samplecollection site at a point of service location. A point of servicelocation may be a location remote to the LBM where a sample may becollected from a subject or provided by a subject. In some embodiments,a sample collection site may be a retailer. Examples of point of servicelocations and retailers are provided in further detail elsewhere herein.In some embodiments, the sample collection site may comprise a device,as described in further detail elsewhere herein.

The LBM may receive information from a sample collection site, and/ormay receive information from a payer. The LBM may provide information toa sample collection site, and/or may provide information to a payer. TheLBM may communicate with the payer and sample collection site in anymanner known or later developed in the art, including, but not limitedto using a sample processing device, network device, mobile device,telephone, postage, courier, delivery, or any other communicationtechniques described elsewhere herein. The communication may occur overa network, including any form of network as described elsewhere herein.One-way or two-way communication may be provided between the LBM and thepayer, and between the LBM and the sample collection site. The LBM,payer, and sample collection site may have one or more communicationunit. The communication unit may be configured to provide communicationbetween the LBM, payer, and sample collection site. The communicationunit may be configured to provide wireless or wired communication.

The LBM may also perform financial transactions with the payer and withthe sample collection site. In some instances, the financialtransactions may be two-way financial transactions, or may be one-wayfinancial transactions. In one example, the payer may pay the LBM. TheLBM may pay the sample collection site. The payment the LBM provides thesample collection site may be derived from the payment the LBM receivesfrom the payer.

The LBM, payer, and sample collection site may have a processor andmemory that may keep track of the communications and/or payments. TheLBM, payer, and/or sample collection site may interact with one or morethird party that may keep track of the communications and/or payments.The one or more third parties may be financial institutions. A processormay have access to one or more memory that may contain information aboutpayments received or disbursed. For example, an LBM may have a processorthat accesses one or more memory or data storage unit containinginformation about a payment received from the payer and a paymentprovided to a sample collection site.

The payments may be provided based on use of a device provided at thesample collection site. The LBM may request a payment from the payerbased on use of the device. The LBM may provide a payment to the samplecollection site based on use of the device. Alternatively, the LBM mayrequest a payment from the sample collection site based on use of thedevice.

The LBM may comprise one or more data storage unit comprisinginformation of the subject, or may have the ability to accessinformation of the subject, said informing comprising insurance statusof said subject, copayment status of prior and pending clinical test(s),medical records relating to the subject, payment information relating tothe subject, identification information of the subject, or otherinformation associate with the subject or financial transactionsassociated with the subject.

In some alternate embodiments, a payer may receive an electronic billfrom a sample collections site and/or an LBM. In some instances, ahealth care professional may receive an electronic payment from thesample collection site and/or the LBM.

FIG. 6 shows a laboratory benefit system provided in accordance with anembodiment of the invention. A point of service 620 may be incommunication with a laboratory 630. The point of service may be asample collection site and any description herein of a point of servicemay also apply to a sample collection site and vice versa. The point ofservice may also be in communication with an LBM 610 who may also be incommunication with a payer 600. The LBM and the laboratory may be incommunication with a health care professional 640. A subject 650 mayprovide a sample to a point of service.

A point of service 620 may be a sample collection center that may have adevice that may be configured to facilitate collection of a biologicalsample from a subject 650. As previously described, the sample may becollected from the subject at the point of service, or may be providedto the device at the point of service.

The sample collection center may be capable of communicating with alaboratory 630. The laboratory may be a certified laboratory. The samplecollection center may communicate with the laboratory via a sampleprocessing device located at the sample collection center. The samplecollection center may communicate with the laboratory in additionalways. Data collected by the device may be transmitted from the point ofservice 620 to the laboratory. Such data may be related to the samplecollected from the subject. Any type of data described previouslyherein, including raw data, pre-processed data, or analyzed data may beprovided to the laboratory.

The laboratory may provide the device to the point of service location.In one example, the laboratory may either sell or lease/rent the deviceto the sample collection center. The laboratory may request a paymentfrom the sample collection center for the sales and/or leasing of thedevice to the sample collection center. The sample collection center mayprovide a payment to the laboratory for the ownership or use of thedevice. The device may be operated by a device operator. The operatormay be affiliated with the point of service location. The operator maybe an employee or otherwise affiliated with the sample collectioncenter. The operator may or may not be trained in the use of the device.The sample collection center may be another entity separate from thelaboratory. The sample collection center may be affiliated with thepoint of service location or may be operated by a separate entity. Thesample collection center may be any of the point of service locationsdescribed elsewhere herein, including but not limited to retailers(e.g., Blue Cross, Blue Shield, Health Net, Aetna, Cigna), hospitals,medical facilities, and any other point of service. In one example, thedevice may be operated by a technician or other individual associatedwith a retailer or other point of service. The laboratory may befunctioning as a wholesaler of the device. Alternatively, one or moreintermediary entities may be provided that may purchase devices from thelaboratory, and in turn provide/sell devices to point of servicelocations.

In an alternate example, the laboratory may pay the point of servicelocation for providing the device at the sample collection center, whichmay be located at the point of service location. The laboratory may paythe point of service location for permitting use of the device at thepoint of service location and for permitting the setup of the samplecollection center at the point of service. For example, the laboratorymay be permitted to rent out space at a retailer, where the laboratorymay setup a sample collection center having one or more devices. Thedevice may be operated by personnel who is or is not trained in the useof the device. The device operator may be affiliated with thelaboratory. The device operator may or may not be an employee of thelaboratory. The device and device operator may be using the point ofservice location as a sample collection site that is remote to thelaboratory.

The laboratory may provide a cartridge to a point of service location.The cartridge may be configured to be inserted into, or otherwiseinterface with the device. The cartridge may or may not be disposable.The laboratory may or may not provide disposables to the servicelocation for use with the device. Any description herein of cartridgesmay also apply to the disposables and vice versa. In one example, thelaboratory may either sell the cartridge to the sample collectioncenter. The sample collection center may be affiliated with the point ofservice location and/or with a separate entity. The sample collectioncenter may be run by the point of service location and/or a separateentity. The laboratory may request a payment from the sample collectioncenter for the sales of the cartridge to the sample collection center.The sample collection center may provide a payment to the laboratory forthe cartridges. The operator of the device may be affiliated with thepoint of service location. The laboratory may be functioning as awholesaler of the cartridge. Alternatively, one or more intermediaryentities may be provided that may purchase cartridges from thelaboratory, and in turn provide/sell cartridges to point of servicelocations.

In an alternate example, the laboratory need not request payment fromthe sample collection center for providing the cartridge at the samplecollection center. The device may be operated by personnel who is or isnot trained in the use of the device. The device operator may beaffiliated with the laboratory. The device operator may or may not be anemployee of the laboratory. The device and device operator may be usingthe point of service location as a sample collection site that is remoteto the laboratory. The cartridge may be used as part of the samplecollection service at the point of service location, for a device thatmay be operated by a laboratory-affiliated individual.

The laboratory 630 may be capable of communicating with a health careprofessional 640. The health care professional may be at a locationseparate from the laboratory and the point of service. The health careprofessional may or may not have an existing relationship with thesubject 650. The health care professional may have issued a prescriptionfor the subject to go to the point of service location and perform oneor more test. The health care professional may or may not have arelationship with point of service or with the laboratory. In someembodiments, the laboratory may send a report to the health careprofessional. The medical report may be based on data collected from adevice at the point of service. The medical report may be based on ananalysis of the data collected from the device. In some embodiments,analysis of data may include the comparison of collected data with oneor more threshold value to determine the presence or concentration of atleast one analyte. In some embodiments, the laboratory may have aprocessor that may be configured to access a data storage unit that mayhave information relating to the one or more threshold value. Theanalysis may occur at the laboratory 630 and the report may be generatedat the laboratory. Alternatively, the analysis may occur at the deviceand the report may be generated by the device or at the laboratory.

In some embodiments, a report may be provided to a subject 650. Thereport transmitted to the subject may or may not be the same as thereport provided to the health care professional 640. The reports may besent simultaneously, or the health care professional may receive thereport first, or vice versa.

An LBM 610 may be provided that may communicate with a payer 600 and apoint of service 620. The LBM may or may not communicate with a healthcare professional 640 and/or a laboratory 630.

The laboratory 630 and LBM 610 may be separate entities. The laboratoryand LBM may be separate corporations, companies, organizations,institutions, partnerships, one or more individuals, or any other typeof entity as described elsewhere herein. The laboratory and LBM may beincorporated as separate legal entities. The LBM may be a laboratorybenefits manager, and the laboratory may be a wholesaler. The laboratoryand LBM may be housed in separate facilities. Alternatively, they mayshare facilities.

The LBM 610 may charge a payer 600 based on use of the device at thepoint of service 620. For example, per use of the device, the LBM maycharge the payer a fee. The size of the fee may depend on one or morefactors, such as the type of use of the device (e.g., number of analyteswhose presence or concentration were detected, the number of chemicalreactions, the amount of sample preparation, the types of reactions thattake place, the number of device components that are used), the analysisconducted in relationship to the data collected from the device (e.g.,more complex analysis may result in a different fee from morestraightforward analysis), the payer relationship with the subject, thepayer relationship with the point of service if any. The LBM and payermay have an agreement in place that may determine the payment planbetween the payer and the LBM.

The LBM 610 may provide a payment to a point of service 620 based on useof the device at the point of service. For example, per use of thedevice, the LBM may provide a payment to the point of service. Inanother example, for the amount of time that the device is located atthe point of service, the LBM may provide a payment to the point ofservice. The size of the fee may depend on one or more factors, such asthe type of use of the device (e.g., number of analytes whose presenceor concentration were detected, the number of chemical reactions, theamount of sample preparation, the types of reactions that take place,the number of device components that are used), the analysis conductedin relationship to the data collected from the device (e.g., morecomplex analysis may result in a different fee from more straightforwardanalysis). The LBM and point of service may have an agreement in placethat may determine the payment plan between the point of service and theLBM and the LBM. In alternate embodiments, the LBM may provide a paymentto a laboratory 630. Any description herein of providing payment to apoint of service may also apply to a laboratory. The LBM may provide apayment to the laboratory instead of providing a payment to the point ofservice, or in addition to providing a payment to the point of service.

In some embodiments, the LBM 610 may divide a payment received from thepayer 600 into a technical fee and a professional fee. In one example,the LBM may provide a payment to a health care professional 640 based onthe professional fee. The LBM may provide a payment to the samplecollection center 620 based on the technical fee. In some embodiments,the sample collection center may be operated by a point of service, suchas a retailer, hospital, or any other point of service. In someembodiments, the sample collection center may be operated by alaboratory. The payment may be provided to the entity for the point ofservice location, or to a laboratory who may be operating a samplecollection center at a point of service location.

The LBM may make the determination of how to divide the payment from thepayer. The technical fee and/or professional fees may be based onagreements that the LBM may have with the health care professional,point of service, and/or laboratory. The professional fee may also oralternatively be based on agreements that the health care professionalmay have with the payer and/or laboratory.

The LBM may further divide the payment from the payer into a transactionfee. The transaction fee may be an amount that goes to the LBM. The LBMmay be able to keep a fraction of the payment made by the payer.

FIG. 7 shows an example of a lab benefits manager/wholesaler model inaccordance with an embodiment of the invention. A retailer 700 (or otherpoint of service), such as a pharmacy, may have one or more sampleprocessing device located at the retailer site. A retailer technicianmay operate the sample processing device, and may place a cartridge intothe device 710. The cartridge may or may not contain a sample from asubject collected at the retailer site.

A laboratory benefit manager 720 may be an LBM as described elsewhereherein. The laboratory benefit manager may be an entity.

A laboratory benefit manager 720 and a wholesaler 730 may be providedwithin the model. The laboratory benefit manager and the wholesaler maybe separate entities. The laboratory benefit manager and the wholesalermay be separate legal entities, corporate entities, corporations,partnerships, organizations, and/or groups of one or more individuals.The laboratory benefit manager and the wholesaler may be housed indifferent facilities or in the same facility.

A laboratory benefit manager 720 may be in communication with one ormore payers 740. The laboratory benefit manager may issue an invoice fora service to the payers. The payer may pay the laboratory benefitmanager. For example, the laboratory benefit manager may request a $a(e.g., $28 to provide a numerical example) fee from the payer, who paysthe laboratory benefit manager, the $a. The laboratory benefit managermay retain a LBM fee. For example, a $b (e.g., $1 to provide a numericalexample) fee may be retained by the laboratory benefit manager.

The laboratory benefit manager 720 may reimburse the retailer 700 forthe balance of the amount. For example, the laboratory benefit managermay pay the retailer the remaining $c, (e.g., $27). $c may equal $aminus $b.

The retailer may also have fees associated with the laboratory benefitmanager and/or the wholesaler. For example, the retailer may have anagent fee that the retailer may pay the laboratory benefit manager. Inone example, the agent fee is $d (e.g., $8 to provide a numericalexample). The retailer may also issue a purchase order or pay for aproduct. For example, the retailer may pay for the purchase or use ofthe device at the retailer site and/or cartridges. The retailer may paythe laboratory benefit manager. Alternatively, the retailer may pay thewholesaler for the purchase or use of the device and/or cartridges. Inone example, the payment for the product may be $e (e.g., $9 to providea numerical example).

From a laboratory benefit manager perspective, there may be a financialbenefit to following the model. For example, the laboratory benefitmanager may receive an LBM fee based on the device use. For example, theLBM fee may be $b per transaction. The laboratory benefit manager mayalso receive an agent fee from the retailer. For example, the laboratorybenefit manager may receive an $d admin fee. In some instances, thelaboratory benefit manager may also receive a product fee from theretailer. For example, the laboratory benefit manager may receive a $eproduct fee.

From a retailer perspective, there may be financial benefit to followingthe model. For example, the retailer may receive a service income of $c.The service income may be provided through the laboratory benefitmanager. The laboratory benefit manager may provide the service incomebased on a payment received from a payer. The laboratory benefit managermay subtract an LBM fee from the amount received from the payer, and maypass the rest on to the retailer as a service income. In additionalembodiments, the laboratory benefit manager may also subtract aprofessional fee, which may be provided to a health care professional orother entity, with the remainder of the balance going to the retailer asa service income. Thus, as shown in FIG. 7, the total revenue may beprovided from a $c service income. Costs to the retailer may include anadministration fee (e.g., the $d fee shown), and/or a product fee (e.g.,the $e fee shown). The costs may be about $f (e.g., $17 to provide anumerical example). $f may equal $d plus $e. The costs to the retailermay be lower than the service income. For example, a $g (e.g., $10 toprovide a numerical example) gross margin is illustrated for theretailer. In some instances, $g=$c minus $f.

The table below illustrates examples of the model.

P & L Impacts Retailer Service Income $c Total Revenue $c COGS $f ($dadmin fee + $e product cost) Gross Margin $g

Any of the dollar amounts are provided by way of example only and shallnot be construed as limiting. Any numerical value may be inserted forthe various dollar values.

In some embodiments, a subject may be associated with a payer. Forexample, a payer, such as a health insurance company, government payer,or any other payer as described herein, may provide coverage for thesubject. A payer may pay some or all of the subject's medical bills. Insome embodiments, when a subject arrives at a point of service, theidentification of the subject may be verified. The identification of thesubject may be verified using the device, and/or verified by personnelat the point of service. For example, the personnel at the point ofservice may view the subject's identification and/or insurance card. Thedevice may or may not capture an image of the subject and/or collect oneor more biometric parameter from the subject. Verification may occuron-board the device. Alternatively, the identification of the subjectmay be collected at the point of service and may be further verified atanother entity or location. For example, a laboratory, health careprofessional, or payer may verify the subject identity. The device,laboratory, health care professional, and/or payer may be capable ofaccessing subject information, such as electronic health records.Verification may occur rapidly and/or in real-time. For example,verification may occur within 10 minutes or less, 5 minutes or less, 3minutes or less, 1 minute or less, 45 seconds or less, 30 seconds orless, 20 seconds or less, 15 seconds or less, 10 seconds or less, 5seconds or less, 3 seconds or less, 1 second or less, 0.5 seconds orless, or 0.1 seconds or less. The verification may be automated withoutrequiring any human intervention.

The system may verify the identity of the subject for the system'srecords, insurance coverage, to prevent fraud, or any other purpose. Theverification may be performed by the device. The verification may occurat any time. In one example, the subject's identity may be verifiedprior to preparing the subject's sample for the test. The subject'sidentity may be verified prior to providing a sample to the deviceand/or cartridge. The verification of the subject's identity may beprovided prior to, currently with, or after verifying the subject'sinsurance coverage. The verification of the subject's identity may beprovided prior to, currently with, or after verifying the subject hasreceived a prescription to undergo said qualitative and/or quantitativeevaluation. The verification may take place through communications withthe medical care provider, laboratory, payer, laboratory benefitsmanager, or any other entity. Verification may occur by accessing one ormore data storage units. The data storage units may include anelectronic medical records database and/or a payer database.Verification may occur rapidly and/or in real-time. For example,verification may occur within 10 minutes or less, 5 minutes or less, 3minutes or less, 1 minute or less, 45 seconds or less, 30 seconds orless, 20 seconds or less, 15 seconds or less, 10 seconds or less, 5seconds or less, 3 seconds or less, 1 second or less, 0.5 seconds orless, or 0.1 seconds or less. The verification may be automated withoutrequiring any human intervention.

The verification may include information provided by the subject. Forexample, the verification may include scanning an identification cardand/or insurance card of the subject. The verification may includetaking a picture of the subject and/or the subject's face. For example,the verification may include taking a two-dimensional orthree-dimensional snapshot of the subject. Cameras may be used which mayprovide a two-dimensional digital image of the subject and/or that maybe capable of formulating a three-dimensional or four-dimensional imageof the subject. A four-dimensional image of the subject may incorporatechanges over time. The verification may include taking a picture of thesubject's face for identification. The verification may include taking apicture of another portion of the subject's face for identification,including but not limited to the patient's whole body, arm, hand, leg,torso, foot, or any other portion of the body. The verification mayemploy a video camera and/or a microphone that may capture additionalvisual and/or audio information. The verification may include comparingthe subject's movements (e.g., gait), or voice.

The verification may include entering personal information related tothe subject, such as the subject's name, insurance policy number,answers to key questions, and/or any other information. The verificationmay include collecting one or more biometric read-out of the subject.For example, the verification may include a fingerprint, handprint,footprint, retinal scan, temperature readout, weight, height, audioinformation, electrical readouts, or any other information. Thebiometric information may be collected by the device. For example, thedevice may have a touchscreen upon which the subject may put thesubject's palm to be read by the device. The touchscreen may be capableof scanning one or more body part of the subject, and/or receiving atemperature, electrical, and/or pressure readout from the subject.Alternatively, the device may receive the biometric information fromother devices. For example, the device may receive the subject's weightfrom a scale that may be separate from the device. The information maybe sent directly from the other devices (e.g., over wired or wirelessconnection) or may be entered manually.

The verification may also include information based on a samplecollected from the subject. For example, the verification may include agenetic signature of the subject. When the sample is provided to thedevice, the device may use at least part of the sample to determine thegenetic signature of the subject. For example, the device may performone or more nucleic acid amplification step and may determine keygenetic markers for the subject. This may form the subject's geneticsignature. The subject's genetic signature may be obtained prior to,concurrently with, or after processing the sample on the device. Thesubject's genetic signature may be stored on one or more data storageunit. For example, the subject's genetic signature may be stored in thesubject's electronic medical records. The subject's collected geneticsignature may be compared with the subject's genetic signature alreadystored in the records, if it exists. Any other unique identifyingcharacteristic of the subject may be used to verify the subject'sidentity.

Methods for the amplification of nucleic acids, including DNA and/orRNA, are known in the art. Amplification methods may involve changes intemperature, such as a heat denaturation step, or may be isothermalprocesses that do not require heat denaturation. The polymerase chainreaction (PCR) uses multiple cycles of denaturation, annealing of primerpairs to opposite strands, and primer extension to exponentiallyincrease copy numbers of the target sequence. Denaturation of annealednucleic acid strands may be achieved by the application of heat,increasing local metal ion concentrations (e.g. U.S. Pat. No.6,277,605), ultrasound radiation (e.g. WO/2000/049176), application ofvoltage (e.g. U.S. Pat. No. 5,527,670, U.S. Pat. No. 6,033,850, U.S.Pat. No. 5,939,291, and U.S. Pat. No. 6,333,157), and application of anelectromagnetic field in combination with primers bound to amagnetically-responsive material (e.g. U.S. Pat. No. 5,545,540), whichare hereby incorporated by reference in their entirety. In a variationcalled RT-PCR, reverse transcriptase (RT) is used to make acomplementary DNA (cDNA) from RNA, and the cDNA is then amplified by PCRto produce multiple copies of DNA (e.g. U.S. Pat. No. 5,322,770 and U.S.Pat. No. 5,310,652, which are hereby incorporated by reference in theirentirety).

One example of an isothermal amplification method is strand displacementamplification, commonly referred to as SDA, which uses cycles ofannealing pairs of primer sequences to opposite strands of a targetsequence, primer extension in the presence of a dNTP to produce a duplexhemiphosphorothioated primer extension product, endonuclease-mediatednicking of a hemimodified restriction endonuclease recognition site, andpolymerase-mediated primer extension from the 3′ end of the nick todisplace an existing strand and produce a strand for the next round ofprimer annealing, nicking and strand displacement, resulting ingeometric amplification of product (e.g. U.S. Pat. No. 5,270,184 andU.S. Pat. No. 5,455,166, which are hereby incorporated by reference intheir entirety). Thermophilic SDA (tSDA) uses thermophilic endonucleasesand polymerases at higher temperatures in essentially the same method(European Pat. No. 0 684 315, which is hereby incorporated by referencein its entirety).

Other amplification methods include rolling circle amplification (RCA)(e.g., Lizardi, “Rolling Circle Replication Reporter Systems,” U.S. Pat.No. 5,854,033); helicase dependent amplification (HDA) (e.g., Kong etal., “Helicase Dependent Amplification Nucleic Acids,” U.S. Pat. Appln.Pub. No. US 2004-0058378 A1); and loop-mediated isothermal amplification(LAMP) (e.g., Notomi et al., “Process for Synthesizing Nucleic Acid,”U.S. Pat. No. 6,410,278), which are hereby incorporated by reference intheir entirety. In some cases, isothermal amplification utilizestranscription by an RNA polymerase from a promoter sequence, such as maybe incorporated into an oligonucleotide primer. Transcription-basedamplification methods commonly used in the art include nucleic acidsequence based amplification, also referred to as NASBA (e.g. U.S. Pat.No. 5,130,238); methods which rely on the use of an RNA replicase toamplify the probe molecule itself, commonly referred to as Qβ replicase(e.g., Lizardi, P. et al. (1988) BioTechnol. 6, 1197-1202);self-sustained sequence replication (e.g., Guatelli, J. et al. (1990)Proc. Natl. Acad. Sci. USA 87, 1874-1878; Landgren (1993) Trends inGenetics 9, 199-202; and HELEN H. LEE et al., NUCLEIC ACID AMPLIFICATIONT ECHNOLOGIES (1997)); and methods for generating additionaltranscription templates (e.g. U.S. Pat. No. 5,480,784 and U.S. Pat. No.5,399,491), which are hereby incorporated by reference in theirentirety. Further methods of isothermal nucleic acid amplificationinclude the use of primers containing non-canonical nucleotides (e.g.uracil or RNA nucleotides) in combination with an enzyme that cleavesnucleic acids at the non-canonical nucleotides (e.g. DNA glycosylase orRNaseH) to expose binding sites for additional primers (e.g. U.S. Pat.No. 6,251,639, U.S. Pat. No. 6,946,251, and U.S. Pat. No. 7,824,890),which are hereby incorporated by reference in their entirety. Isothermalamplification processes can be linear or exponential.

Nucleic acid amplification for subject identification may comprisesequential, parallel, or simultaneous amplification of a plurality ofnucleic acid sequences, such as about, less than about, or more thanabout 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 50, 100, or moretarget sequences. In some embodiments, a subjects entire genome orentire transcriptome is non-specifically amplified, the products ofwhich are probed for one or more identifying sequence characteristics.An identifying sequence characteristic includes any feature of a nucleicacid sequence that can serve as a basis of differentiation betweenindividuals. In some embodiments, an individual is uniquely identifiedto a selected statistical significance using about, less than about, ormore than about 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 50, 100, ormore identifying sequences. In some embodiments, the statisticalsignificance is about, or smaller than about 10⁻², 10⁻³, 10⁻⁴, 10⁻⁵,10⁻⁶, 10⁻⁷, 10⁻⁸, 10⁻⁹, 10⁻¹⁰, 10⁻¹¹, 10⁻¹², 10⁻¹³, 10⁻¹⁴, 10⁻¹⁵, orsmaller. Examples of identifying sequences include Restriction FragmentLength Polymorphisms (RFLP; Botstein, et al., Am. J. Hum. Genet. 32:314-331, 1980; WO 90/13668), Single Nucleotide Polymorphisms (SNPs;Kwok, et al., Genomics 31: 123-126, 1996), Randomly AmplifiedPolymorphic DNA (RAPD; Williams, et al., Nucl. Acids Res. 18: 6531-6535,1990), Simple Sequence Repeats (SSRs; Zhao & Kochert, Plant Mol. Biol.21: 607-614, 1993; Zietkiewicz, et al. Genomics 20: 176-183, 1989),Amplified Fragment Length Polymorphisms (AFLP; Vos, et al., Nucl. AcidsRes. 21: 4407-4414, 1995), Short Tandem Repeats (STRs), Variable Numberof Tandem Repeats (VNTR), microsatellites (Tautz, Nucl. Acids. Res. 17:6463-6471, 1989; Weber and May, Am. J. Hum. Genet. 44: 388-396, 1989),Inter-Retrotransposon Amplified Polymorphism (IRAP), Long InterspersedElements (LINE), Long Tandem Repeats (LTR), Mobile Elements (ME),Retrotransposon Microsatellite Amplified Polymorphisms (REMAP),Retrotransposon-Based Insertion Polymorphisms (RBIP), Short InterspersedElements (SINE), and Sequence Specific Amplified Polymorphism (SSAP).Additional examples of identifying sequences are known in the art, forexample in US20030170705, which is incorporated herein by reference. Agenetic signature may consist of multiple identifying sequences of asingle type (e.g. SNPs), or may comprise a combination of two or moredifferent types of identifying sequences in any number or combination.

Genetic signatures can be used in any process requiring theidentification of one or more subjects, such as in paternity ormaternity testing, in immigration and inheritance disputes, in breedingtests in animals, in zygosity testing in twins, in tests for inbreedingin humans and animals; in evaluation of transplant suitability such aswith bone marrow transplants; in identification of human and animalremains; in quality control of cultured cells; in forensic testing suchas forensic analysis of semen samples, blood stains, and otherbiological materials; in characterization of the genetic makeup of atumor by testing for loss of heterozygosity; and in determining theallelic frequency of a particular identifying sequence. Samples usefulin the generation of a genetics signature include evidence from a crimescene, blood, blood stains, semen, semen stains, bone, teeth, hair,saliva, urine, feces, fingernails, muscle or other soft tissue,cigarettes, stamps, envelopes, dandruff, fingerprints, items containingany of these, and combinations thereof. In some embodiments, two or moregenetic signatures are generated and compared. In some embodiments, oneor more genetics signatures are compared to one or more known geneticsignatures, such as genetic signatures contained in a database.

A system may also verify whether the subject has received instruction toundergo a clinical test from a health care professional. The system maythus verify whether a subject has received an order from a health careprofessional to undertake a qualitative and/or quantitative evaluationof a biological sample. For example, the system may verify whether thesubject has received a prescription from the health care professional totake the test. The system may verify whether the subject has receivedinstructions from the health care professional to provide a sample tothe device. The system may also verify whether the subject wasauthorized to go to a particular point of service to undergo the test.The verification may occur with aid of the device. The verification mayoccur at any time. In one example, the subject's authorization to takethe test may be verified prior to preparing the subject's sample for thetest. The subject's authorization to take the test may be verified priorto providing a sample to the device and/or cartridge. The verificationof the subject's authorization may be provided after verifying thesubject's identification. The verification of the subject'sauthorization may be provided before or after verifying the subject hasinsurance coverage for the clinical test. The system may verify whetherthe subject is covered by health insurance for a qualitative and/orquantitative evaluation of a sample, within the verifying step isperformed prior to, concurrently with, or after processing a biologicalsample with the aid of a device, or transmitting the data from thedevice. The verification may take place through communications with themedical care provider, laboratory, payer, laboratory benefits manager,or any other entity. Verification may occur rapidly and/or in real-time.For example, verification may occur within 10 minutes or less, 5 minutesor less, 3 minutes or less, 1 minute or less, 45 seconds or less, 30seconds or less, 20 seconds or less, 15 seconds or less, 10 seconds orless, 5 seconds or less, 3 seconds or less, 1 second or less, 0.5seconds or less, or 0.1 seconds or less. The verification may beautomated without requiring any human intervention.

The system may also verify whether the subject has insurance coveragefor the clinical test. The system may verify whether the subject hasinsurance coverage to provide a sample to the device. The system mayalso verify whether the subject has insurance coverage for going to thepoint of service and undergoing the test. The verification may occur atany time. In one example, the subject's insurance coverage may beverified prior to preparing the subject's sample for the test. Thesubject's insurance coverage may be verified prior to providing a sampleto the device and/or cartridge. The verification of the subject'sinsurance coverage may be provided after verifying the subject'sidentification. The verification of the subject's insurance coverage maybe provided before or after verifying the subject has received aprescription to take the clinical test. The verification may take placethrough communications with the medical care provider, laboratory,payer, laboratory benefits manager, or any other entity. Theverification may occur with the aid of the device. Verification mayoccur rapidly and/or in real-time. For example, verification may occurwithin 10 minutes or less, 5 minutes or less, 3 minutes or less, 1minute or less, 45 seconds or less, 30 seconds or less, 20 seconds orless, 15 seconds or less, 10 seconds or less, 5 seconds or less, 3seconds or less, 1 second or less, 0.5 seconds or less, or 0.1 secondsor less. The verification may be automated without requiring any humanintervention.

The system may also verify whether the clinical test is appropriate forthe subject. The system may verify whether an order for a qualitativeand/or quantitative evaluation is within a set of policy restrictions.Such policy restrictions may form guidelines. Such policy restrictionsmay be policy restriction of a payer, prescribing physician or otherordering health care professional, laboratory, governmental orregulatory body, or any other entity. Such verification may depend onone or more known characteristic of the subject including but notlimited to gender, age, or past medical history. A clinical decisionsupport system may be provided. The system may be capable of accessingone or more medical records, or information associated with the subject.The system may be able to access records relating to the identity of thesubject, insurance coverage of the subject, past and present medicaltreatments of the subject, biological features of the subject, and/orprescriptions provided to the subject. The system may be able to accesselectronic health records and/or pull up patient records and history.The system may also be able to pull up payer records, such as insuranceand financial information relating to the subject. The verification mayoccur with the aid of the device.

In some embodiments, prior to providing a qualitative and/orquantitative evaluation, the system may be capable of accessing one ormore records database and/or payer database. In some instances, thesystem may be capable of determining which records database and/or payerdatabase to access prior to providing said qualitative and/orquantitative evaluation, and/or prior to accessing said databases. Thesystem may make such determination based on the subject's identity, thesubject's payer information, information collected about the sample, theproposed qualitative and/or quantitative evaluation, and/or any otherinformation.

In one example, an inappropriate test may be a pregnancy test for a malesubject or a PSA level (prostrate-specific antigen) for a femalesubject. Such tests may fall outside the policy restrictions of a payeror prescribing physician. Such ordering errors may be detectable byreviewing the test ordered and information associated with the subject.Such information associated with the subject may include medical recordsfor the subject or identifying information about the subject. In oneexample, the appropriateness of the test is verified prior to preparingthe subject's sample for the test. The subject's test appropriatenessmay be verified prior to, concurrently with, or subsequent to providinga sample to the device and/or cartridge. The verification of thesubject's test appropriateness may be provided after or prior toverifying the subject's identification and/or insurance coverage. Theverification may take place through communications with the medical careprovider, laboratory, payer, laboratory benefits manager, or any otherentity. A clinical decision support system may operate rapidly and/or inreal-time. For example, verification may occur within 10 minutes orless, 5 minutes or less, 3 minutes or less, 1 minute or less, 45 secondsor less, 30 seconds or less, 20 seconds or less, 15 seconds or less, 10seconds or less, 5 seconds or less, 3 seconds or less, 1 second or less,0.5 seconds or less, or 0.1 seconds or less. The clinical decisionsupport system may be automated without requiring any humanintervention.

In some embodiments, qualified personnel may assist with collecting thesubject's identity and/or providing a sample from the subject to thedevice. The qualified personnel may be an authorized technician that hasbeen trained to use the device. The qualified personnel may be adesignated operator of the device. The qualified personnel may or maynot be a health care professional. In some embodiments, the identity ofthe qualified personnel may be verified. The qualified personnel'sidentity may be verified prior to, currently with, or after receivingthe biological sample, transmitting the data from the deviceelectronically and/or analyzing the transmitted data. The qualifiedpersonnel's identity may be verified prior to, currently with, or afterverifying the identity of the subject. The qualified person's identitymay be verified using one or more of the techniques described elsewhereherein.

It should be understood from the foregoing that, while particularimplementations have been illustrated and described, variousmodifications can be made thereto and are contemplated herein. It isalso not intended that the invention be limited by the specific examplesprovided within the specification. While the invention has beendescribed with reference to the aforementioned specification, thedescriptions and illustrations of the preferable embodiments herein arenot meant to be construed in a limiting sense. Furthermore, it shall beunderstood that all aspects of the invention are not limited to thespecific depictions, configurations or relative proportions set forthherein which depend upon a variety of conditions and variables. Variousmodifications in form and detail of the embodiments of the inventionwill be apparent to a person skilled in the art. It is thereforecontemplated that the invention shall also cover any such modifications,variations and equivalents.

1. A method of evaluating a biological sample collected from a subject,said method comprising: (a) receiving data transmitted from a ClinicalLaboratory Improvement Amendments (CLIA)-compliant device placed in oron the subject or at a site selected from the group consisting of aretailer site, the subject's home, or a health assessment/treatmentlocation, wherein the device is configured to process the biologicalsample by: (i) receiving the biological sample; (ii) preparing thebiological sample and yielding raw data for a subsequent qualitativeand/or quantitative evaluation of said biological sample; and (iii)transmitting electronically the raw data to an authorized analyticalfacility and/or an affiliate thereof for performance of said subsequentevaluation; (b) analyzing the raw data transmitted from the device atthe authorized analytical facility and/or the affiliate thereof, toprovide said evaluation of said biological sample, wherein said analysisis performed using a processor alone or in conjunction with anindividual affiliated with the authorized analytical facility; and (c)providing oversight of integrity of said analysis and operation of saidCLIA-compliant device such that results generated from said analysis canbe utilized by a health care professional for diagnosis or treatment ofsaid subject, wherein the oversight is performed using a processor aloneor in conjunction with an individual affiliated with the authorizedanalytical facility, and wherein the authorized analytical facility is aCLIA-compliant laboratory.
 2. The method of claim 1, wherein theevaluation of said biological sample is effected without transportingsaid sample from the site where the sample is collected to theauthorized analytical facility and/or an affiliate thereof.
 3. Themethod of claim 1, wherein the biological sample is selected from thegroup consisting of blood, serum, plasma, nasal swab or nasopharyngealwash, saliva, urine, tears, gastric fluid, spinal fluid, stool, mucus,sweat, earwax, oil, glandular secretion, cerebral spinal fluid, tissue,semen, and vaginal fluid, throat swab, breath, hair, finger nails, skin,biopsy, placental fluid, amniotic fluid, cord blood, emphatic fluids,cavity fluids, sputum, mucus, puss, micropiota, meconium, breast milkand/or other excretions.
 4. The method of claim 1, wherein thebiological sample has a volume of 250 uL or less.
 5. The method of claim1, wherein said oversight includes the selection of the analysismethodology and procedures.
 6. The method of claim 1, further comprisingthe step of verifying insurance eligibility of said subject prior to,concurrent with or subsequent to said analysis.
 7. The method of claim1, further comprising generating a report for said subject based on saidevaluation.
 8. A method of evaluating a biological sample collected froma subject, said method comprising: (a) receiving electronic datarepresentative of an image of said biological sample and/or an image ofa physical process or chemical reaction performed with said biologicalsample or a portion thereof, said data being transmitted from a ClinicalLaboratory Improvement Amendments (CLIA)-compliant device placed in oron the subject or at a designated sample collection site, wherein thedevice is configured to process the biological sample by: (i) receivingthe biological sample; (ii) preparing the biological sample and yieldingthe electronic data representative of the image of said biologicalsample and/or the image of the physical process or the chemicalreaction; and (iii) transmitting the electronic data representative ofthe image to an authorized analytical facility and/or an affiliatethereof for performance of an evaluation; wherein the processinggenerates the electronic data representative of the image necessary forthe evaluation of said biological sample, and (b) analyzing theelectronic data representative of the image transmitted from the deviceat the authorized analytical facility and/or the affiliate thereof, toprovide said evaluation of said biological sample, wherein said analysisis performed using a processor alone or in conjunction with anindividual affiliated with the authorized analytical facility; and (c)providing oversight of integrity of said analysis and operation of saidCLIA-compliant device such that results generated from said analysis canbe utilized by a health care professional for diagnosis or treatment ofsaid subject, wherein the oversight is performed using a processor aloneor in conjunction with an individual affiliated with the authorizedanalytical facility, and wherein the authorized analytical facility is aCLIA-compliant laboratory.
 9. The method of claim 8, wherein theevaluation of said biological sample is effected without transportingsaid sample from the site where the sample is collected to theauthorized analytical facility and/or an affiliate thereof.
 10. Themethod of claim 8, wherein the biological sample is selected from thegroup consisting of blood, serum, plasma, nasal swab or nasopharyngealwash, saliva, urine, tears, gastric fluid, spinal fluid, stool, mucus,sweat, earwax, oil, glandular secretion, cerebral spinal fluid, tissue,semen, and vaginal fluid, throat swab, breath, hair, finger nails, skin,biopsy, placental fluid, amniotic fluid, cord blood, emphatic fluids,cavity fluids, sputum, mucus, puss, micropiota, meconium, breast milkand/or other excretions.
 11. The method of claim 8, wherein thebiological sample has a volume of 250 uL or less.
 12. The method ofclaim 8, wherein said oversight includes the selection of the analysismethodology and procedures.
 13. The method of claim 8, furthercomprising the step of verifying insurance eligibility of said subjectprior to, concurrent with or subsequent to said analysis.
 14. The methodof claim 8, further comprising generating a report for said subjectbased on said evaluation.
 15. A method of evaluating a plurality oftypes of biological samples collected from a subject, said methodcomprising: (a) receiving data transmitted from a Clinical LaboratoryImprovement Amendments (CLIA)-compliant device placed in or on thesubject or at a designated sample collection site, wherein the device isconfigured to process the plurality of types of biological samples by:(i) receiving the plurality of types of biological samples; (ii)preparing the biological samples and yielding raw data for a subsequentqualitative and/or quantitative evaluation of said plurality of types ofbiological samples; and (iii) transmitting electronically the raw datato an authorized analytical facility and/or an affiliate thereof forperformance of said subsequent evaluation; (b) analyzing the raw datatransmitted from the device at the authorized analytical facility and/orthe affiliate thereof, to provide said evaluation of said plurality oftypes of biological samples, wherein said analysis is performed using aprocessor alone or in conjunction with an individual affiliated with theauthorized analytical facility; and (c) providing oversight of integrityof said analysis and operation of said CLIA-compliant device such thatresults generated from said analysis can be utilized by a health careprofessional for diagnosis or treatment of said subject, wherein theoversight is performed using a processor alone or in conjunction with anindividual affiliated with the authorized analytical facility, andwherein the authorized analytical facility is a CLIA-compliantlaboratory.
 16. The method of claim 15, wherein the evaluation of saidbiological samples is effected without transporting said samples fromthe site where the samples are collected to the authorized analyticalfacility and/or an affiliate thereof.
 17. The method of claim 15,wherein the biological samples are selected from the group consisting ofblood, serum, plasma, nasal swab or nasopharyngeal wash, saliva, urine,tears, gastric fluid, spinal fluid, stool, mucus, sweat, earwax, oil,glandular secretion, cerebral spinal fluid, tissue, semen, and vaginalfluid, throat swab, breath, hair, finger nails, skin, biopsy, placentalfluid, amniotic fluid, cord blood, emphatic fluids, cavity fluids,sputum, mucus, puss, micropiota, meconium, breast milk and/or otherexcretions.
 18. The method of claim 15, wherein each of the biologicalsamples has a volume of 250 uL or less.
 19. The method of claim 15,wherein said oversight includes the selection of the analysismethodology and procedures.
 20. The method of claim 15, furthercomprising the step of verifying insurance eligibility of said subjectprior to, concurrent with or subsequent to said analysis.
 21. The methodof claim 15, further comprising generating a report for said subjectbased on said evaluation.
 22. A system of evaluating a biological samplecollected from a subject, said system comprising: (a) a communicationunit configured to receive data from a Clinical Laboratory ImprovementAmendments (CLIA)-compliant device placed in or on the subject or at adesignated sample collection site, wherein the device is configured toprocess the biological sample, thereby generating raw data for asubsequent qualitative and/or quantitative evaluation of said biologicalsample, and wherein the device comprises (i) a sample collection unitconfigured to receive the biological sample; (ii) a sample preparationunit configured to prepare the biological sample and to yield raw datafor the evaluation; and (iii) transmission unit configured to transmitthe raw data to an authorized analytical facility and/or an affiliatethereof; (b) a processor that processes said data alone or inconjunction with an individual affiliated with the authorized analyticalfacility for the evaluation of said biological sample at the authorizedanalytical facility and/or the affiliate thereof, and for the oversightof said integrity of evaluation and operation of said CLIA-compliantdevice such that results generated from said evaluation can be utilizedby a health care professional for diagnosis or treatment of saidsubject, wherein the authorized analytical facility is a CLIA-compliantlaboratory, and wherein said processor communicates with a recorddatabase comprising one or more medical records and/or insuranceinformation of the subject.
 23. The system of claim 22, wherein theprocess is configured to communicate with a payer database comprisingthe insurance information for the subject.
 24. The system of claim 22,wherein the device is configured to receive information relating to saidevaluation and optionally display said information on said device.